Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Dropizol 10mg/ml oral drops
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Opium tincture may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for Dropizol is an herbal medicinal product that contains morphine. Dropizol belongs to a group of medicines called antipropulsives and is used in adults to treat severe diarrhoea, when use of other anti-diarrhoea treatments have not given sufficient effect. Dropizol works by inhibiting the movements of the intestine.
What you need to know before you take it
e Dropizol Do not take Dropizol:
- If you are allergic to opium or morphine or any of the other ingredients of this medicine (listed in section 6)
- If you have opiate dependency
- If you suffer from glaucoma (raised pressure in the eye)
- If you have severe liver or kidney disease
- If you have alcohol withdrawal symptoms (delirium tremens).
- If you have a severe head trauma
- If you are at risk of paralytic ileus (obstruction of the intestine due to paralysis of the intestinal muscles)
- If you suffer from acute asthma
- a chronic pulmonary disease that makes it hard to breathe (COPD)
- If you have breathing problems because of severe respiratory depression. Your doctor will have told you if you have any of these conditions. Symptoms may include breathlessness, coughing or breathing more slowly or weakly than expected
- If you have heart failure secondary to lung disease (cor pulmonale)
- If you are breast-feeding
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Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Dropizol: • • • • • • • • • • • • • • • • • •
If you are elderly, as elderly people may react differently to this medicine. The dose may need to be adjusted. If you have a chronic kidney and/or liver disease. The dose may need to be adjusted. If you are addicted to narcotics or alcohol If you have gallbladder disease or gallstones If you have a head injury or increased pressure in the brain If you have reduced consciousness If you are taking medication for depression (moclobemide or other MAO-inhibitors) or have stopped using this medication within the last 2 weeks If you have reduced adrenal glands function If you have underactive thyroid, the dose may need to be adjusted. Low blood pressure with decreased blood volume Inflammation of the pancreas If you have prostatic hyperplasia (enlargement of the prostate) and/or conditions predisposing to urinary retention. If you have an infection or inflammation of the intestines since inhibition of peristalsis may increase the risk of uptake of toxins and development of an enlarged colon and perforation of your intestines. If you suffer from epilepsy If you take other medicines against diarrhoea If you experience seizures If you have a bleeding in your stomach and/or intestines If you take medicine against increased blood pressure
If you experience difficulty to urinate a health care professional should be contacted. Dropizol is not recommended before surgery or within 24 hours after operation due to risk of paralytic ileus. The symptoms of which are nausea and vomiting. Risk for dependence and tolerance when using the product. Children and adolescents Dropizol should not be used in children and adolescents aged below 18 years Other medicines and Dropizol Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. It is especially important that you tell your doctor or pharmacist if you are taking: •
Medicines that potentiate the reduced consciousness and difficulty breathing, seen with Dropizol, such as
- Alcohol
- Sleeping medicines (e.g. zolpidem) and general anaesthetics (e.g. barbiturates)
- Medicines to treat depression (Tricyclic antidepressants) or Parkinson's disease (MAOinhibitors, e.g. safinamide)
- Antipsychotic medicines with a sedative action (e.g. phenothiazines)
- Medicines to treat epilepsy (gabapentin)
- Medicines to relieve nausea and vomiting (e.g. bromopride, meclizine, metoclopramide)
- Medicines to relieve allergy (antihistamines, e.g. carbinoxamine, doxylamine)
- Other opioid pain relievers (e.g. alfentanil, butorphanol, fentanyl, hydrocodone, hydromorphone, levorphanol, meperidine, methadone, oxycodone, oxymorphone, remifentanil, sufentanil, tapentadol, tramadol). 2
• • • • • • • • • •
Medicines that have a similar mode of action as morphine and therefore may increase withdrawal symptioms and reduce therapeutic effect (buprenorphine, nalbuphine, nalmefene, naltrexone, pentazocine) Medicines to treat alcohol abuse (disulfiram) or medicines to treat certain kinds of infections (metronidazole) as this might cause unpleasant side effects such as flushing, rapid breathing and fast heart rate Medicines to treat tuberculosis (rifampicin) decreases the effect of morphine Some medicines used to treat blood clots (e.g. clopidogrel, prasugrel, ticagrelor) may have delayed and decreased effect when taken together with opium Concomitant administration of antacids may cause a faster release of morphine than expected; therefore, dosing should not take place at the same time, but with an interval of at least 2 hours.Amphetamine and analogues can reduce the sedative effect of opioids. Loxapine and periciazine can increase the sedative effect of opioids. Concomitant use of flibanserin and opioids may increase the risk of CNS depression. Opioids can increase the plasma concentrations of desmopressin and sertraline Zidovudine (medicine to treat or prevent HIV infections). Medicines to treat depression (fluoxetine) might reduce the duration of action of morphine
Concomitant use of Dropizol and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes Dropizol together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor. Please tell your doctor about all sedative medicines you are taking and follow your doctor's dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor if you experience such symptoms. Concurrent administration of morphine may increase the effects of drugs that decrease your blood pressure or other drugs with a lowering effect on your blood pressure. Dropizol with food, drink and alcohol Dropizol can be taken with food and drink. Dropizol contains alcohol, so extra care should be exercised when consuming alcohol. See "Dropizol contains ethanol" below. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy Do not take Dropizol during pregnancy unless your doctor has told you to. Dropizol should not be taken close to the date to give birth due to the risk of withdrawal symptoms in the neonate. Breastfeeding Dropizol must not be used during breastfeeding. Fertility It is unknown whether Morphine may harm your fertility. Fertile men and women should use effective contraception when using Dropizol. Driving and using machines Dropizol contains morphine and ethanol and it may cause drowsiness and significantly affect your ability to drive or operate machines. 3
Do not drive after taking your medicines until you know how they affect you. Dropizol contains ethanol This medicinal product contains 33 vol % ethanol (alcohol), i.e. up to 260 mg per dose, equivalent to 6.6 ml of beer or 2.8 ml of wine per dose. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
How to take it
Dropizol Always take this medicine exactly as your doctor told you. Check with your doctor or pharmacist if you are not sure. The recommended dose in adults is: Adults: 5-10 drops 2-3 times daily. Single dose should not exceed 1 ml and the total daily dose should not exceed 6 ml. Elderly: The dosage should be reduced initially. Hepatic impairment: Dropizol should not be used or the dosage should be reduced. Please see section 2 "Do not take" and section 2 "Warnings and precautions". Renal impairment: Dropizol should not be used or the dosage should be reduced. Please see section 2 "Do not take" and section 2 "Warnings and precautions". There are 20 drops in 1 ml. Method of administration: Oral use. Dropizol can be used undiluted or mixed in a glass of water. After mixture with water, it should be used immediately. If Dropizol is used undiluted the correct dosage can be administered with a spoon.
1. Opening of the child-resistant closure: Push down and turn.
2. Hold the bottle vertically and drip onto a spoon or into a glass.
Use in children and adolescents Dropizol should not be used in children and adolescents below 18 years. If you take more Dropizol than you should If you take too much Dropizol you may experience small pupils, slow heartrates, low blood pressure, lung edema, breathing difficulties and depressed levels of consciousness which may lead to coma. Call your doctor if you have taken more Dropizol than your doctor has prescribed for you or as stated in this leaflet and you feel uncomfortable. 4
If you forget to take Dropizol You should take the missed dose as soon as you remember, unless it is nearly time for the next dose. Do not take a double dose to make up for a forgotten dose. If you stop taking Dropizol Continue taking the medicine as long as your doctor has told you to. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Serious side effects Common (may affect up to 1 in 10 people): Difficulty urinating Uncommon (may affect up to 1 in 100 people): Shortness of breath, fatigue, anxiety, bluish tinge of the lips, fingers and toes, headaches, confusion, seizures and swelling in the legs and feet (Respiratory depression). Cardiac arrhythmia (fast or slow heartbeat) Other side effects Very common (may affect more than 1 in 10 people): Drowsiness and constipation, dry mouth Common (may affect up to 1 in 10 people): Dizziness, headache, pupil contraction, nausea and vomiting, loss of appetite, indigestion or discomfort, changes in taste and smell, urticaria, sweating, bronchospasm, decreased coughing, asthenia Uncommon (may affect up to 1 in 100 people): Facial flushing, itching, spasms in the lower urinary tract, abnormal liver tests Rare (may affect up to 1 in 1,000 people): Increase in pancreatic enzymes (seen in a blood test) and inflammation of the pancreas, pain because of kidney stones (renal colic) or gallstones (biliary colic), withdrawal symptoms, orthostatic hypotension (a form of low blood pressure that happens when you stand up from sitting or lying down) Very rare (may affect up to 1 in 10,000 people): Difficulty breathing, muscle cramp, seizures, burning and stinging pain, increased sensitivity to pain, blurred vision, double vision, involuntary movement of the eye, a condition where the bowel does not work properly (ileus), abdominal pain, rash, swelling of the hands, ankles or feet, feeling unwell, shivering, syndrome of inappropriate antidiuretic hormone (SIADH) (symptoms: nausea, malaise, headache, exhaustion and in severe cases may progress to seizures and coma), absence of menstrual bleeding. Not known (frequency cannot be estimated from the available data): Adrenal insufficiency (fatigue, weight loss, fainting, low blood sugar, nausea, diarrhea, vomiting and abdominal pain), Euphoria (strong sense of well-being, happiness and excitement), uncontrolled muscle movements, addiction, dysphoric mood (sad, without energy), restlessness, decreased libido or potency, hallucinations, vertigo and fever. Reporting of side effects 5
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
Dropizol Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and bottle. The expiry date refers to the last day of that month. Do not refrigerate or freeze. After first opening, the bottle may be used for 4 weeks. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What Dropizol contains
- The active substance is: Opium tincture
- 1 ml of oral liquid contains 1 ml of tincture from Papaver somniferum L., succus siccus (Opium, raw) corresponding to 10 mg of morphine. 1 drop contains 50 mg opium tincture equivalent to 0.5 mg (10 mg/ml) anhydrous morphine. 1 ml contains 20 drops.
- Extraction solvent: 33 % ethanol (V/V) –
–
Excipients Ethanol 96% V/V Purified water
What Dropizol looks like and contents of the pack Dropizol is a dark, reddish brown liquid. It is available in a brown glass bottle with dropper and a child-resistant closure. Pack sizes 1 x 10 ml, 3 x 10 ml, 4 x 10 ml, 5 x 10 ml and 10 x 10 ml. Not all pack sizes may be marketed Marketing Authorisation Holder Pharmanovia A/S Ørestads Boulevard 108, 5 DK-2300 København S Denmark E-mail: [email protected] Manufacturer Lomapharm GmBH Langes Feld 5 D-31860 Emmerthal 6
Germany Atnahs Pharma Denmark ApS Copenhagen Towers, Ørestads Boulevard 108, 5.tv, DK-2300 København S, Denmark This medicinal product is authorised in the Member States of the EEA under the following names: Danmark: Island: Finland: Norge: Sverige: UK: Austria: Belgium: Czech Republic: Germany: Spain: France: Hungary: Ireland: Italy: Luxembourg: Netherlands: Portugal: Romania: Slovak Republic:
Dropizol Dropizol Dropizol Dropizol Dropizol Dropizol Dropizol Dropizole Dropizol Dropizol Dropizol Dropizal Dropizol Dropizol Dropizole Dropizol Dropizol Dropizale Dropizol Dropizol
This leaflet was last revised in 02-2024
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Frequently asked questions about Dropizol 10mg/ml oral drops
How do I take Dropizol 10mg/ml oral drops?
Dropizol 10mg/ml oral drops comes as drops containing 10mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Dropizol 10mg/ml oral drops?
The active substance in Dropizol 10mg/ml oral drops is opium tincture.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Dropizol 10mg/ml oral drops, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Dropizol 10mg/ml oral drops without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: opium tincture
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Symptomatic treatment of severe diarrhoea in adults, when use of other anti-diarrhoea treatments have not given sufficient effect.
4.2. Posology and method of administration
Posology
Usual starting dose in adults: 5–10 drops, 2–3 times daily.
Individual doses should not exceed 1 ml, and the total daily dose should not exceed 6 ml
The posology should be individualized to use the lowest effective dose for the shortest duration of time taking into account the patient's general condition, the patient's age, weight, and medical history (see sections 4.3 and 4.4).
Paediatric population
Dropizol should not be used in children and adolescents aged below 18 years for safety reasons, see section 5.1.
Treatment should be initiated and supervised by a specialist, e.g. oncologist or gastroenterologist.
Particular caution should be exercised when prescribing this drug due to its morphine content. The treatment period should be as short as possible.
Elderly
Caution should be exercised, and the dosage initially reduced in treatment of elderly subjects.
Hepatic impairment
Morphine may precipitate coma in hepatic impairment – avoid or reduce dose. See Sections 4.3 and 4.4.
Renal impairment
Elimination is reduced and delayed in renal impairment - avoid or reduce dose. See Sections 4.3 and 4.4.
Method of administration
Oral use.
The product can be used undiluted or mixed in a glass of water. After mixture with water, it should be used immediately. If the product is used undiluted the correct dosage can be administered with a spoon.
4.3. Contraindications
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
• Opiate dependency.
• Glaucoma.
• Severe hepatic or renal impairment.
• Delirium tremens.
• Severe head trauma.
• Risk of paralytic ileus.
• Chronic obstructive pulmonary disease
• Acute asthma
• Severe respiratory depression with hypoxia and/or hypercapnia
• Heart failure secondary to lung disease (Cor pulmonale)
Breastfeeding, see section 4.6
4.4. Special warnings and precautions for use
Dropizol should only be used following investigations of the etiology causing the symptoms and when first-line treatment has not given adequate results.
Dropizol drops should be used with caution in the following conditions / for the following patients:
• The elderly
• Chronic renal disease and/or hepatic disease.
• Alcoholism.
• Biliary colic, cholelithiasis, biliary duct diseases
• Head injuries or increased intracranial pressure
• Reduced consciousness
• Cardiorespiratory shock
• Monoamine oxidase inhibitors (including moclobemide), or within two weeks of their withdrawal
• Adrenocortical deficiency
• Hypothyroidism
• Low blood pressure with hypovolaemia
• Pancreatitis
• Prostatic hyperplasia and other conditions predisposing to urinary retention
• Concomitant administration of other antidiarrheal or antiperistaltic drugs, anticholinergics, antihypertensives, see section 4.5.
• Convulsive disorders
• Gastrointestinal haemorrhage
A health care professional should be contacted in case of difficulty to urinate.
Adjustment of dose may be needed in the elderly, patients with thyroid insufficiency, and patients with mild to moderate renal or hepatic impairment (see also section 4.2 and 4.3).
Avoid use in older adults with a history of falls or fractures as ataxia, impaired psychomotor function, syncope, and additional falls may occur. If use is necessary, consider reducing use of other CNS-active agents that increase risk of falls and fractures and implement other strategies to reduce risk of falls.
Anti-diarrheals inhibiting peristalsis should be used with caution in patients with infection or inflammatory bowel diseases due to the increased risk of absorption of toxins, and of developing toxic megacolon and intestinal perforation. Due to the risk of paralytic ileus, Dropizol is not recommended before a surgical operation or within 24 hours after operation. If paralytic ileus is suspected during the use of Dropizol, the treatment must be stopped immediately.
Repeated administration may cause dependence and tolerance and the use of opium may lead to addiction to the substance. Particular caution should be exercised in individuals predisposed to addiction to narcotics and alcohol.
Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs
Concomitant use of Dropizol and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe Dropizol concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.
The patients should be followed closely for signs and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients and their caregivers to be aware of these symptoms (see section 4.5).
Administer at reduced doses and with the utmost caution to patients who are also being treated with other narcotic agents, sedatives, and tricyclic antidepressants and MAO-inhibitors (see also section 4.2).
Oral P2Y12 inhibitor antiplatelet therapy
Within the first day of concomitant P2Y12 inhibitor and morphine treatment, reduced efficacy of P2Y12 inhibitor treatment has been observed (see section 4.5).
Should only be used with caution in patients in high-risk groups, such as patients with epilepsy and hepatic disease.
Opioids may inhibit the hypothalamic–pituitary–adrenal (HPA) or gonadal axis at multiple levels and is most pronounced after long term use.
This may lead to symptoms of adrenal insufficiency (see also section 4.8).
This medicinal product contains 33 vol % ethanol (alcohol), i.e. up to 260 mg per dose, equivalent to 6.6 ml beer or 2.8 ml wine.
4.5. Interaction with other medicinal products and other forms of interaction
The risk of sedation, respiratory depression, coma or death increases because of additive CNS depressant effect by ethanol, hypnotics (e.g. zolpidem), general anaesthetics (e.g. barbiturates), MAO inhibitors (e.g. safinamide), tricyclic antidepressants and psychotropic drugs with a sedative action (e.g. phenothiazines), gabapentin, antiemetic medications (e.g. bromopride, meclizine, metoclopramide), antihistamines (e.g. carbinoxamine, doxylamine), and other opioids (e.g. alfentanil, butorphanol, fentanyl, hydrocodone, hydromorphone, levorphanol, meperidine, methadone, oxycodone, oxymorphone, remifentanil, sufentanil, tapentadol, tramadol). The dose and duration of concomitant use should be limited (see section 4.4). Dropizol should not be used with other morphine agonists/antagonists (buprenorphine, nalbuphine, nalmefene, naltrexone, pentazocine) because of their competitive receptor-binding that may aggravate withdrawal symptoms and reduce therapeutic effect
Due to the ethanol content, Dropizol should not be used concomitantly with disulfiram or metronidazole. Both of these drugs can cause disulfiram-like reactions (flushing, rapid breathing, tachycardia).
Rifampicin induces CYP 3A4 in the liver thus increasing the metabolism of morphine, codeine and methadone. The effect of these opioids is thereby decreased or counteracted.
A delayed and decreased exposure to oral P2Y12 inhibitor antiplatelet therapy has been observed in patients with acute coronary syndrome treated with morphine. This interaction may be related to reduced gastrointestinal motility and apply to other opioids. The clinical relevance is unknown, but data indicate the potential for reduced P2Y12 inhibitor efficacy in patients co-administered morphine and a P2Y12 inhibitor (see section 4.4). In patients with acute coronary syndrome, in whom morphine cannot be withheld and fast P2Y12 inhibition is deemed crucial, the use of a parenteral P2Y12 inhibitor may be considered.
Concurrent administration of morphine and antihypertensive drugs may increase the hypotensive effects of antihypertensive agents or other drugs with hypotensive effects.
Morphine inhibits the glucuronidation of zidovudine in vitro.
Morphine's duration of action may be reduced after taking fluoxetine.
Cimetidine and ranitidine do not affect the bioavailability of opium, oral drops.
Other drug-drug interactions
Amphetamine and analogues can reduce the sedative effect of opioids. Loxapine and periciazine can increase the sedative effect of opioids. Concomitant use of flibanserin and opioids may increase the risk of CNS depression. Opioids can increase the plasma concentrations of desmopressin and sertraline.
Ethanol, see Section see 4.4.
4.6. Fertility, pregnancy and lactation
Pregnancy
There is limited amount of data from the use of opium in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3).
Dropizol is not recommended during pregnancy unless the benefits clearly outweigh the risks to both mother and child.
When morphine is used during pregnancy up to partition, neonatal withdrawal syndrome can occur.
Breastfeeding
Opium is excreted in human milk. If the patient is a ultra-rapid metaboliser of CYP2D6, higher levels of morphine (due to increased metabolism of codeine) may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant, which may be fatal. Dropizol is contraindicated during breastfeeding, (see section 4.3).
Fertility
There are insufficient data to assess human risk to fertility. Animal studies have shown chromosomal damage in reproductive cells (see section 5.3). Men and women of reproductive age should take necessary precautions.
4.7. Effects on ability to drive and use machines
Due to its undesirable effects, Dropizol may have a major influence on the ability to drive and use machines.
4.8. Undesirable effects
The adverse events reported for Dropizol drops are derived from literature and post-marketing experience with other morphine products.
Endocrine disorders
Very rare /<1/10,000)
Syndrome of inadequate ADH-secretion (SIADH), Amenorrhoea
Not known (cannot be estimated from the available data)
Adrenal insufficiency
Psychiatric disorders
Not known (cannot be estimated from the available data)
Addiction, dysphoric mood, restlessness, decreased libido or potency, hallucinations.
Nervous system disorders
Very common (≥1/10)
Drowsiness
Common (≥1/100 to <1/10)
Dizziness, headache
Very rare (<1/10,000)
Muscle cramps, seizures, allodynia and hyperalgesia
Not known (cannot be estimated from the available data)
Euphoria
Eye disorders
Common (≥1/100 to <1/10)
Miosis
Very rare (<1/10,000)
Blurred vision, diplopia, nystagmus
Cardiac disorders
Uncommon (≥1/1,000 to <1/100)
Tachycardia, bradycardia, palpitations, facial flushing
Vascular disorders
Rare (≥1/10,000 to <1/1,000)
Orthostatic hypotension
Respiratory, thoracic and mediastinal disorders
Common (≥1/100 to <1/10)
Bronchospasms, cough decreased
Uncommon (≥1/1,000 to <1/100)
Respiratory depression
Very rare /<1/10,000)
Dyspnoea
Gastrointestinal disorders
Very common (≥1/10)
Constipation, dry mouth
Common (≥1/100 to <1/10)
Nausea, vomiting, loss of appetite, dyspepsia, dysgeusia
Rare (≥1/10,000 to <1/1,000)
Pancreatic enzymes increase and pancreatitis
Very rare /<1/10,000)
Ileus, abdominal pain
Hepatobiliary disorder
Uncommon (≥1/1,000 to <1/100)
Hepatic enzymes increased
Rare (≥1/10,000 to <1/1,000)
Biliary colic
Skin and subcutaneous tissue disorders
Common (≥1/100 to <1/10)
Urticaria, sweating
Uncommon (≥1/1,000 to <1/100)
Pruritus
Very rare /<1/10,000)
Exanthema, peripheral oedema
Musculoskeletal and connective tissue disorders
Not known (cannot be estimated from the available data)
Involuntary muscle contractions
Renal and urinary disorders
Common (≥1/100 to <1/10)
Urinary retention
Uncommon (≥1/1,000 to <1/100)
Urethral spasm
Rare (≥1/10,000 to <1/1,000)
Renal colic
General disorders and administration site conditions
Common (≥1/100 to <1/10)
Asthenia
Rare (≥1/10,000 to <1/1,000)
Withdrawal symptoms
Very rare /<1/10,000)
Feeling unwell, shivering
Not known (cannot be estimated from the available data)
Hyperthermia, vertigo
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V
4.9. Overdose
Morphine toxicity. Lethal doses are primarily determined by the morphine content.
Symptoms of overdose
Miosis, respiratory depression, somnolence, reduced skeletal muscle tone and drop in blood pressure. In severe cases circulatory collapse, stupor, coma, bradycardia and non-cardiogenic lung oedema, hypotension and death may occur; abuse of high doses of strong opioids such as oxycodone can be fatal.
Therapy of overdose
Primary attention should be given to the establishment of a patent airway and institution of assisted or controlled ventilation.
In the event of overdosing intravenous administration of an opiate antagonist may be indicated.
Furthermore, gastric lavage can be taken into consideration.
Supportive treatment (artificial respiration, oxygen supply, administration of vasopressors and infusion therapy) should, if necessary, be applied in the treatment of accompanying circulatory shock.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Not the same combination. This medicine contains Opium tincture. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
- DROPIZOL 10 mg/ml prescription partial — not the same combinationOPIUM · taken by mouth
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
💬 Ask about this leaflet
Ask anything about Dropizol 10mg/ml oral drops. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.