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Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Demeclocycline Hydrochloride 300 mg Capsules

⚠ 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 Demeclocycline hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Demeclocycline hydrochloride
Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

for Demeclocycline Hydrochloride Capsules contain the active substance demeclocycline hydrochloride. This is an antibiotic (kills bacteria) belonging to the tetracycline group of antibiotics. It is used to treat a wide range of infections caused by bacteria. Some of these infections are: Ÿ Severe acne Ÿ Infections of the brain and liver caused by the bacteria Leptospira Ÿ Infection caused by Brucella bacteria (brucellosis) Ÿ Infections caused by Rickettsiae micro-organisms transmitted by lice, fleas, ticks and mites Ÿ Infections of the sex organs and organs associated with urination (genito-urinary infections) such as an infection called chancroid, nongonococcal urethritis Ÿ Rare infections such as Tularaemia and bubonic plague. It may also be used to treat a rare condition in which a tumour of the pituitary gland in your brain causes the amount of sodium in your blood to be too low.

What you need to know before you take it

e Demeclocycline Hydrochloride Capsules DO NOT take Demeclocycline Hydrochloride Capsules if: Ÿ You know that you are allergic to any tetracycline antibiotic, including Demeclocycline, or to any of the other ingredients (see section 6 of this leaflet) Ÿ You have a genetic disorder of your enzymes called acute porphyria. This may affect your nervous system and cause abdominal pain, vomiting and weakness Ÿ You have severe problems with your kidneys Ÿ If the patient is under 12 years of age. Speak to your doctor if any of these apply to you before you start taking this product. Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Demeclocycline Hydrochloride Capsules if you: Ÿ Are sensitive to the sun, or have ever had any sun related skin reactions. You should avoid direct sunlight or using sunlamps while you are taking this medicine Ÿ Are suffering from any disease which affects your liver or kidneys which is not severe Ÿ Suffer from myasthenia gravis, a condition characterized by muscle weakness, difficulty chewing and swallowing and slurred speech Ÿ Suffer from Systemic Lupus Erythematosus, known as SLE (which is an allergic condition which causes joint pain, skin rashes and fever).

Other medicines and Demeclocycline Hydrochloride Capsules: Tell your doctor or pharmacist if you are taking, or have recently taken or might take any other medicines. In particular, the effects of Demeclocycline Hydrochloride Capsules may be altered if you are already taking: Ÿ Warfarin, coumarins and phenindione which are medicines used to thin your blood Ÿ Retinoids (such as acitretin or isotretinoin), which are used for acne treatment Ÿ Penicillin antibiotics (e.g. amoxicillin) Ÿ Migraine treatments e.g. ergotamine and methysergide Ÿ Sucralfate and tripotassium dicitrato bismuthate, which are medicines used to treat stomach or gut ulcers Ÿ Oral typhoid vaccine Ÿ Strontium ranelate which is used to treat bone diseases Ÿ Diarrhoea medicines e.g. kaolin Ÿ Antacid medicines which contain magnesium or aluminium Ÿ Supplements or medicines which contain iron, calcium, zinc, magnesium or aluminium. If you need to go to the hospital for an operation whilst you are taking this product, tell your doctor that you are taking Demeclocycline Hydrochloride Capsules. Demeclocycline Hydrochloride Capsules with food and drink: The capsules should be swallowed whole with a glass of water and on an empty stomach. Demeclocycline Hydrochloride Capsules will be less effective if taken at the same time as food, milk, dairy products or supplements containing iron, calcium, zinc, magnesium or aluminium (see instructions in Section 3 "How to take Demeclocycline Hydrochloride Capsules"). Pregnancy and breast feeding: 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. Demeclocycline Hydrochloride Capsules should not be taken during pregnancy and breast-feeding. Driving and using machines: This medicine can cause headaches, dizziness and disturbances in vision and rarely, with hearing. If this happens to you, do not drive or operate machinery until these symptoms have gone away or until you have finished taking the capsules.

How to take it

Demeclocycline Hydrochloride Capsules Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The following information is to give you an idea of the usual doses given to treat particular illnesses. Different doses may be prescribed and if this applies to you, discuss it with your doctor. You should complete the course of capsules as prescribed by your doctor. For most infections: A total of 4 capsules every day are needed. These can be taken as 2 capsules in the morning and 2 in the evening, or as 1 capsule four times a day. For pneumonia: 2 capsules are usually taken three times a day. For the treatment of low sodium in the blood: The starting dose is between 6 and 8 capsules each day, divided equally over the day. After a while this dose is reduced to between 4 and 6 capsules each day. Ÿ Never take more capsules than the doctor has told you to. It will not help you get better any faster and could be harmful to you Ÿ The capsules should be swallowed whole with plenty of water. You should take them while you are sitting or standing. Do not take them when you are lying down Ÿ These capsules are best taken on an empty stomach. To make sure of this you should not eat a meal for at least an hour before, or for two hours after you need to take a dose. If you take them closer to a mealtime, there will be food in your stomach and they will not work as well. You should avoid large milky drinks during this time as well, although a small amount in tea or coffee doesn't matter Ÿ Some medicines and vitamin/mineral products can stop this medicine working properly if they are taken together. These include indigestion remedies (antacids) and vitamin/mineral products that contain iron, calcium, zinc, magnesium or aluminium in any form. If you need to take any of these while you are taking Demeclocycline Hydrochloride, you should take them at least an hour before or two hours after taking your Demeclocycline Hydrochloride dose.

If you take more Demeclocycline Hydrochloride Capsules than you should: If you accidentally take too many capsules, call your doctor straightaway, or go to the nearest hospital casualty department. Take any remaining capsules and this leaflet with you so that the medical staff know what you have taken. If you forget to take Demeclocycline Hydrochloride Capsules: Take a dose as soon as you remember, and then carry on as before. However you should not take any more capsules than usual on one day to catch up for those missed on the previous day. Do not take two doses at the same time. If you are not sure, ask your doctor or pharmacist for advice. If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Demeclocycline Hydrochloride Capsules can cause side effects, although not everybody gets them. All medicines can cause allergic reactions although serious allergic reactions are rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor immediately. If you notice any of the following side effects, stop taking the medicine and talk to your doctor as soon as possible. Not known (frequency cannot be estimated from the available data) Ÿ wheezing or shortness of breath Ÿ blistering or bleeding of the skin around the lips, eyes, mouth, nose and genitals. Also flu-like symptoms and fever. This may be something called 'Stevens-Johnson syndrome' Ÿ unusual bruising Ÿ severe watery diarrhoea, unusually dark urine or a large increase or sudden decrease in the amount of urine, or a change in the frequency with which you need to pass water. You may become very thirsty and need to go to the toilet a lot more often than usual Ÿ difficulty in swallowing Ÿ weak feeling in your muscles Ÿ severe chest pains, or severe pain in the stomach Ÿ blurred vision, or a very bad headache that will not go away Ÿ liver, kidney problems and disturbances of blood cells (shown by blood tests) have been reported, (symptoms of which include yellowing of the skin and whites of the eyes, sore throat, mouth ulcers, difficulty in passing urine, back pain).

How to store it

Demeclocycline Hydrochloride Capsules Ÿ Keep this medicine out of the sight and reach of children. Ÿ Store in original package in order to protect from light and moisture. Ÿ Do not use after the expiry date. This date is printed on your pack. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

0304-0305/L-3

Contents of the pack and other information

What Demeclocycline Hydrochloride Capsules Contain: The active substance contains either 150 mg or 300 mg of demeclocycline hydrochloride. The other ingredients are: microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate and gelatin capsule shell. Capsule shell contains iron oxide yellow (E172), iron oxide red (E172), titanium dioxide (E171), gelatin and purified water. What Demeclocycline Hydrochloride Capsules looks like and contents of the pack: Demeclocycline Hydrochloride 150 mg Capsules are light brown caps with dirty yellow body hard gelatin size '2' capsule filled with yellow granular powder. Demeclocycline Hydrochloride 300 mg Capsules are maroon caps with dirty yellow body hard gelatin size '0' capsule filled with yellow granular powder. Pack size: Blister pack of 28 capsules Manufacturer: Drugsrus Limited 5 Sandridge Close, Harrow, Middlesex, HA1 1XD, United Kingdom Marketing Authorisation Holder: DAWA Limited 5 Sandridge Close, Harrow, Middlesex, HA1 1XD, United Kingdom This leaflet was last revised in October 2024

Blind or partially sighted? Is this leaflet hard to see or read? Call 020 8423 2111 to obtain the leaflet in a format suitable for you.

Most of the other side effects that may occur are mild and can include: Ÿ an upset stomach, feeling sick or being sick Ÿ heartburn Ÿ dizziness, disturbed hearing Ÿ thrush (vaginal itch and discharge caused by fungal infection) Ÿ increased sensitivity to the sun/sunlamps (possibly causing sunburn). Reporting of side effects 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 MHRA Yellow Card Scheme at: 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.

Frequently asked questions about Demeclocycline Hydrochloride 300 mg Capsules

How do I take Demeclocycline Hydrochloride 300 mg Capsules?

Demeclocycline Hydrochloride 300 mg Capsules comes as capsule containing 300mg. 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 Demeclocycline Hydrochloride 300 mg Capsules?

The active substance in Demeclocycline Hydrochloride 300 mg Capsules is demeclocycline hydrochloride.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Demeclocycline Hydrochloride 300 mg Capsules, 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 Demeclocycline Hydrochloride 300 mg Capsules 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.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Demeclocycline hydrochloride (3 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

For the treatment of infections caused by tetracycline-sensitive organisms. For example, Demeclocycline is highly effective in the treatment of infections caused by Borrelia recurrentis (relapsing fever), Calymmatobacterium granulinatis (granuloma inguinale), Chlamydia species (psittacosis, lymphogranuloma vereneum, trachoma, inclusion conjunctivitis), Francisella tularensis (tularaemia), Haemophilus ducreyi (chancroid), Leptospira (meningitis, jaundice), Mycoplasma pneumoniae (non-gonococcal urethritis), Pseumomonas mallei and pseudomallei (glanders and melioidosis), Rickettsiae (typhus fever, Q fever, rocky mountain spotted fever), Vibrio species (cholera). It is also highly effective, alone or in combination with streptomycin, in the treatment of infections due to Brucella species (brucellosis) and Yersinia pestis (bubonic plague). Severe acne vulgaris.

Other sensitive organisms include: Actinomyces israelii, Bacillus anthracis (pneumonia), Clostridium species (gas gangrene, tetanus), Entamoeba histolytica (dysentery), Neisseria gonorrhoeae and anaerobic species, Treponema pallidum and pertenue (syphilis and yaws).

For the treatment of chronic hyponatraemia associated with the syndrome of inappropriate secretion of antidiuretic hormone (SIADH) secondary to malignant disease, where water restriction is ineffective and the patient does not have concomitant cirrhosis.

4.2. Posology and method of administration

Posology

For Antibiotic Use:

Adults

(Capsules) - 600mg daily in 2 or 4 divided doses. For primary atypical pneumonia, the average daily dose is 900mg in 3 divided doses for 6 days.

Elderly

Use with caution in elderly patients. (See Section 4.3 Contraindications and Section 4.4 Special warnings and special precautions for use)

Paediatric population

Not recommended for children under 12 years of age.

For the treatment of Chronic Hyponatraemia due to SIADH:

Adults only

Initially: 900mg-l200mg daily in divided doses

Maintenance dose: 600-900mg daily in divided doses

Demeclocycline hydrochloride capsule should be swallowed whole with plenty of fluid while sitting or standing. Doses should be taken an hour before or 2 hours after meals as absorption of demeclocycline hydrochloride capsule is impaired by milk and food. Antibiotic therapy should be continued for one to three days after characteristic symptoms of fever have subsided. The incidence of rheumatic fever or glomerulonephritis following streptococcal infections suggests that therapy of a streptococcal infection should be continued for 8 full days even though symptoms have subsided.

Demeclocycline hydrochloride capsule therapy in the treatment of chronic hyponatraemia due to SIADH should not be withdrawn without commencing other methods of control.

Method of administration

Oral administration.

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

The use of Demeclocycline is contraindicated in patients with acute porphyria, patients who are pregnant or breast-feeding, children under 12 years of age, patients with a history of hypersensitivity to tetracyclines and patients with renal impairment.

4.4. Special warnings and precautions for use

Demeclocycline hydrochloride capsule should be used with caution in patients with renal or hepatic dysfunction, or in conjunction with other potentially hepatotoxic or nephrotoxic drugs. Concurrent use with the anaesthetic methoxyflurane increases the risk of kidney failure. The anti-anabolic action of the tetracyclines may cause an increase in BUN. The treatment of chronic hyponatraemia may necessitate the administration of high doses of demeclocycline hydrochloride capsule for prolonged periods, so increasing the potential for nephrotoxicity (manifested by rises in plasma urea and creatinine) and photoallergic reactions. Cross-resistance between tetracyclines may develop in micro-organisms and cross sensitisation in patients. Demeclocycline hydrochloride capsule should be discontinued if there are signs/symptoms of overgrowth of resistant organisms including candida, enteritis, glossitis, stomatitis, vaginitis, pruritis ani or staphylococcal enterocolitis.

Lower doses are indicated in cases of renal impairment to avoid excessive systemic accumulation and if therapy is prolonged, serum level determinations are advisable. Patients who have known liver disease should not receive more than 1g daily. In long term therapy, periodic laboratory evaluation of organ systems, including haematopoietic, renal and hepatic studies should be performed.

Demeclocycline hydrochloride capsule has the greatest potential of the tetracycline analogues for causing photo-allergic reactions in hypersensitive persons. Such patients should be warned to avoid direct exposure to natural or artificial sunlight and to discontinue therapy at the first sign of skin discomfort. Exacerbation of pre-existing SLE has been reported with tetracyclines.

Demeclocycline hydrochloride capsule may increase muscle weakness in patients with myasthenia gravis.

4.5. Interaction with other medicinal products and other forms of interaction

Demeclocycline hydrochloride capsule should not be used with penicillins.

Tetracyclines depress plasma prothrombin activity and reduced doses of concomitant anti-coagulants such as Coumarins and phenindione may be required.

Absorption of demeclocycline hydrochloride capsule is impaired by the concomitant administration of milk and dairy products, food, iron, calcium, zinc, magnesium and particularly aluminium salts commonly used as antacids.

Absorption of tetracyclines is possibly reduced by kaolin, quinapril tablets (quinapril tablets contain magnesium carbonate), strontium ranelate, sucralfate, tripotassium dicitratobismuthate.

There is a possible increased risk of benign intracranial hypertension with concomitant use of tetracyclines and retinoids, e.g. acitretin, isotretinoin, tretinoin. There is increased risk of ergotism when tetracyclines given with ergotamine and methysergide.

Typhoid Vaccine (oral): Antibacterials inactivate oral typhoid vaccine and therefore Demeclocycline Hydrochloride Capsule should be avoided for 3 days before and after oral typhoid vaccine.

4.6. Fertility, pregnancy and lactation

Demeclocycline hydrochloride capsule is contra-indicated during pregnancy and lactation.

Pregnancy

Results of animal studies indicate that tetracyclines cross the placenta, are found in foetal tissues and can have toxic effects on the developing foetus (often related to retardation of skeletal development). Evidence of embryotoxicity has also been noted in animals treated early in pregnancy.

The use of tetracyclines during tooth development (last half of pregnancy and children to the age of 12 years) may cause permanent discoloration of the teeth (yellow-grey-brown). This adverse reaction is more common during long term use of the drugs but has been observed following repeated short term courses. Enamel hypoplasia has also been reported.

Breast-feeding

Tetracyclines have been found in the milk of lactating women who are taking a drug in this class. Permanent tooth discoloration may occur in the developing infant and enamel hypoplasia has been reported. Therefore, demeclocycline hydrochloride capsule should not be administered to lactating women.

4.7. Effects on ability to drive and use machines

Headache, dizziness, visual disturbances and rarely impaired hearing have been reported with tetracyclines and patients should be warned about the possible hazards of driving or operating machinery during treatment.

4.8. Undesirable effects

The following undesirable effects have been reported for Demeclocycline hydrochloride.

The undesirable effects are listed according to their frequency:

Not known (cannot be estimated from the available data)

System organ class

Frequency

Undesirable effects

Blood and lymphatic system disorders

Not Known

Haemolytic anaemia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia and eosinophiliaa

Immune system disorders

Not Known

Hypersensitivity reactions including urticaria, Stevens-Johnson syndrome, angioneurotic oedema, anaphylaxis, anaphylactoid purpura, pericarditis and exacerbation of systemic lupus erythematosus

Nervous system disorders

Not Known

Headache, dizziness, bulging fontanelles (in infants), benign intracranial hypertension (in juveniles and adults), raised intracranial pressure (such as severe or persistent headache or blurred vision) b, myasthenia

Eye disorders

Not Known

Visual disturbances

Ear and labyrinth disorders

Not Known

Impaired hearing

Gastrointestinal disorders

Not Known

Nausea, vomiting, diarrhoea, dysphagia, oesophagitis, oesphageal ulcerationc, candidiasis, pseudomembranous colitis (Clostridium difficile overgrowth) glossitis, stomatitis, vaginitis, or staphylococcal enterocolitis, pancreatitis

Skin and subcutaneous tissue disorders

Not Known

Photosensitivity, erythematous, maculo-papular rashes, pruritus, bullous dermatoses, exfoliative dermatitis, skin discolouration, serious skin reactions

Renal and urinary disorders

Not Known

Renal dysfunction, especially in patients with pre-existing renal impairment, acute renal failure or nephritis, reversible nephrogenic diabetes insipidus (prolonged and/or at high dosages)

Hepatobiliary disorders

Not Known

Hepatitis, jaundice, hepatic failure

Investigations

Not Known

Transient increases in liver function test values

a. When given over prolonged periods, tetracyclines have been reported to produce brown-black discoloration of the thyroid gland. No abnormalities of thyroid function are known to occur.

b. While the condition and related symptoms usually resolve soon after discontinuation of the tetracycline, the possibility of permanent sequelae exists.

c. In patients taking oral tetracyclines in solid dose form, usually where medication was taken immediately before retiring or with inadequate fluids.

Reporting of Adverse reactions

Reporting suspected adverse reactions after authorization 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

No specific antidote. Gastric lavage plus oral administration of milk or antacids. Maintain fluid and electrolyte balance.

💬 Ask about this leaflet

Ask anything about Demeclocycline Hydrochloride 300 mg Capsules. 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.

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