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The product code for this leaflet is: PL 10590/0019

 

Tetralysal 300

Company Details

Galderma (U.K) Ltd


Meridien House69-71 Clarendon RoadWatfordHertfordshireWD17 1DS
Telephone:
Fax:
Medical Information e-mail:info.uk@galderma.com
[view all information leaflets from this company]

PACKAGE LEAFLET: INFORMATION FOR THE USER

Tetralysal® 300 mg Hard Capsules

Lymecycline

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Tetralysal is and what it is used for
2. What you need to know before you take Tetralysal
3. How to take Tetralysal
4. Possible side effects
5. How to store Tetralysal
6. Contents of the pack and other information

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1. What Tetralysal is and what it is used for

Tetralysal belongs to a group of medicines called tetracycline antibiotics.

The main use of Tetralysal is to treat acne. Acne appears as blackheads and whiteheads which people often refer to as pimples or spots.

Tetralysal attacks the bacteria that are one of the main causes of acne. The name of these bacteria is propionibacterium acnes.

This medicine can also be used to treat many other infections caused by bacteria. If you are not sure why you have been prescribed this medicine, talk to your doctor.

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2. What you need to know before you take Tetralysal

Do not take Tetralysal if:

  • you are pregnant, planning to become pregnant or are breast-feeding
  • you are allergic to lymecycline or to other tetracycline antibiotics such as doxycycline or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include either a rash or itching
  • you have ever had kidney disease

Tetralysal must not be given to children under 12 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tetralysal.

Tell your doctor before taking Tetralysal if you

  • have ever had a liver problem
  • suffer from systemic lupus erythematosus (an allergic condition that causes joint pain, skin rashes or fever) or Myasthenia Gravis (a disease that weakens the muscles).

Other medicines and Tetralysal

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Tell your doctor if you are taking any of the following medicines:

  • medicines to thin your blood e.g. warfarin
  • diuretics (used to treat kidney disease, heart disease or high blood pressure)
  • other medicines to treat acne.

Do not take the following medicines at the same time as your Tetralysal as these could affect how well your acne medicine works. Wait at least two hours after taking Tetralysal before you take these types of products.

  • indigestion remedies
  • ulcer healing drugs
  • quinapril (for high blood pressure)
  • supplements containing calcium, aluminium, magnesium, zinc or iron.

If you take a contraceptive pill, it may not work properly while you are taking Tetralysal, especially if you have sickness or diarrhoea for any reason. An additional “barrier” method of contraception (e.g a condom) should be used to make sure you don’t get pregnant. Please read the leaflet that you got with your “pill” or talk to your doctor or pharmacist if you are not sure what to do or how long to take these precautions for.

Tetralysal with food and drink

Absorption of Tetralysal is not affected by moderate amounts of milk. Tetralysal capsules should always be taken with a glass of water.

Pregnancy and breast-feeding

Tetralysal must not be taken if you are pregnant or breast feeding.

Use of medicines such as Tetralysal may affect the proper growth of developing teeth and lead to permanent discolouration.

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.

Driving and using machines

Tetralysal is not known to affect the ability to drive or use machines.

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3. How to take Tetralysal

Always take this medicine exactly as your doctor has told you. The correct dose will be shown on the label which your pharmacist has placed on the container. Check with your doctor or pharmacist if you are not sure.

Please tear the aluminium strip carefully to remove capsule.

Adults and children over 12 years

Acne

The normal dose is one Tetralysal capsule once a day, preferably in the morning. Tetralysal capsules should always be taken with a glass of water.

How long you will have to take Tetralysal for will depend on how quickly your condition improves. For acne, this will normally be at least 8 weeks.

Infections

The normal dose is one Tetralysal capsule twice a day. Your doctor may recommend a lower or higher dose depending on the severity and type of infection. Ask your doctor if you are unsure.

Tetralysal capsules should always be taken with a glass of water.

Do not give Tetralysal to children below the age of 12, it could harm them.

If you take more Tetralysal than you should

If you, or anyone else, take too many Tetralysal capsules phone your doctor for advice or go to your nearest hospital so that medical staff are made aware of the problem.

Don’t forget to take the container with you. This could indicate how many capsules have been taken.

If you forget to take Tetralysal

Do not worry if you forget to take your Tetralysal at the right time. Take it when you remember and carry on as before unless it is time for the next dose. Do not double up the dose to make up for a forgotten capsule. You should never take more capsules than your doctor recommends.

If you stop taking Tetralysal

Acne responds slowly to antibiotics. It is important that you take all the Tetralysal that your doctor has prescribed for you. If you stop taking Tetralysal too soon, your acne or infection could get worse or come back.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tetralysal may cause the following side effects.

Common: may affect up to 1 in 10 people

  • nausea (feeling sick)
  • abdominal pain
  • diarrhoea
  • headache

Not known: frequency cannot be estimated from the available data

  • allergic (hypersensitivity) reaction causing swelling of the eyes, lips or tongue*
  • blistering or peeling of large areas of the skin*
  • ulcerations or lesions on the mouth, lips, genital or anal regions*
  • disturbances of eyesight
  • dizziness
  • vomiting (being sick)
  • yellowing of the skin or eyes (jaundice)
  • increased sensitivity of the skin to sunlight
  • increased pressure in the brain
  • changes in the number or type of certain blood cells
  • pain in the upper part of the abdomen
  • changes in some blood tests (tests of liver function)
  • fever
  • itchiness, skin rash or hives
  • inflammation of the intestine

The following side effects may occur during treatment with the class of medicines to which Tetralysal belongs (the tetracyclines):

  • inflammation or ulceration of the gullet, causing pain or difficulty swallowing or painful heartburn.
  • difficulty in swallowing
  • inflammation of the pancreas
  • liver damage
  • teeth discolouration
  • inflammation or soreness of the tongue, mouth, cheeks, gums or lips
  • soreness or itching of the genital area
  • yeast infection around the anus or genitals
  • infection of the colon
  • permanent visual loss

*Tell your doctor immediately if you develop side effects such as swollen face, lips, tongue and throat, difficulty in breathing, hives, blistering or peeling of large areas of skin, ulcerations or lesions on the mouth, lips, genital or anal regions, severe or persistent headaches or visual disturbances.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

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5. How to store Tetralysal

  • 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. The expiry date refers to the last day of that month.
  • Do not store above 25°C. Store in the original container.

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.

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6. Contents of the pack and other information

What Tetralysal contains

The active substance is lymecycline. Each capsule contains 408mg of lymecycline. The other ingredients are magnesium stearate and colloidal hydrated silica.

The capsule shells contain gelatin, titanium dioxide (E171), erythrosine (E127), quinoline yellow (E104) and indigotine (E132).

What Tetralysal looks like and contents of the pack

Tetralysal capsules are red and yellow. Tetralysal is available in a carton containing 28 or 56 capsules packed in polyethylene/foil blisters. Each blister strip contains 4 capsules and there are 7 or 14 blister strips in each carton.

A carton containing 28 capsules in PVC/foil blisters (14 capsules in two calendar strips) is also approved. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Galderma (UK) Limited
Meridien House
69-71 Clarendon Road
Watford
Herts
WD17 1DS
UK

(PL 10590/0019)

Manufacturer:

Laboratoires Sophartex
B.P. 129
28501 Vernouillet
France

or

Laboratoires Galderma
74540 Alby-Sur-Cheran
France
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This leaflet was last revised in 08/2013.

P23873-5


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