Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
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.
for 2. What you need to know before you take Demeclocycline Hydrochloride Capsules 3. How to take Demeclocycline Hydrochloride Capsules 4. Possible side effects 5. How to store Demeclocycline Hydrochloride Capsules 6. Contents of the pack and other information 1. What are Demeclocycline Hydrochloride Capsules and what are they used 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:
e Demeclocycline Hydrochloride capsules Do not take Demeclocycline Hydrochloride Capsules if:
Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Demeclocycline Hydrochloride Capsules if you:
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.
Demeclocycline Hydrochloride Capsules Always take Demeclocycline Hydrochloride Capsules 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.
4. 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)
not listed in this leaflet. You can also report side effects directly via the MHRA 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.
Demeclocycline Hydrochloride Capsules
What Demeclocycline Hydrochloride Capsules Contain: The active substance is 150mg of demeclocycline hydrochloride. The other ingredients are: powdered cellulose, magnesium stearate, colloidal anhydrous silica and a gelatin capsule shell coloured with red iron oxide (E172), yellow iron oxide (E172), erythrosine (E127), titanium dioxide (E171). Printing ink consists of shellac NF (E904), iron oxide black (E172), purified water, propylene glycol (E1520), dehydrated alcohol, strong ammonia solution, potassium hydroxide and isopropyl alcohol. What Demeclocycline Hydrochloride Capsules looks like and contents of the pack: Demeclocycline Hydrochloride Capsules are hard shell capsules size 0, cap: dark red printed in black 'FW' body: peach printed in black '154'. Demeclocycline Hydrochloride Capsules are available in containers of 20, 28 and 100 capsules, bottles of 100 capsules or blister pack of 20 capsules (not all pack sizes are marketed). Marketing Authorisation Holder Mercury Pharmaceuticals Ltd., Dashwood House, 69 Old Broad Street, London, EC2M 1QS, United Kingdom Manufacturer: Haupt Pharma Berlin GmbH, Moosrosenstrasse 7, 12347 Berlin, Germany. Alternate Manufacturer: Mercury Pharmaceuticals Limited Dashwood House, 69 Old Broad Street, London, EC2M 1QS, United Kingdom
This leaflet was last revised in August 2023.
Demeclocycline Hydrochloride 150mg Capsules comes as capsule containing 150mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Demeclocycline Hydrochloride 150mg Capsules is demeclocycline hydrochloride.
Medicines with the same active substance, strength and form include: Demeclocycline Hydrochloride 150 mg Capsule. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Demeclocycline Hydrochloride 150mg Capsules, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
For the treatment of infections caused by tetracycline-sensitive organisms. For example, LEDERMYCIN 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.
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 Contra-indications 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
LEDERMYCIN 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 LEDERMYCIN 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.
LEDERMYCIN 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.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
The use of LEDERMYCIN 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.
LEDERMYCIN 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 LEDERMYCIN 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. LEDERMYCIN 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.
LEDERMYCIN 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.
LEDERMYCIN may increase muscle weakness in patients with myasthenia gravis.
LEDERMYCIN 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 LEDERMYCIN 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 Ledermycin should be avoided for 3 days before and after oral typhoid vaccine.
LEDERMYCIN 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, LEDERMYCIN should not be administered to lactating women.
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.
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 ulceration,c 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.
Management
No specific antidote. Gastric lavage plus oral administration of milk or antacids. Maintain fluid and electrolyte balance.
Ask anything about Demeclocycline Hydrochloride 150mg 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.
We use essential cookies to make the site work. We would also like to set optional cookies to understand how the site is used, so we can improve it. We will not set optional cookies unless you accept. See our cookie policy and privacy policy.