Active substance: LYMECYCLINE

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300 mg Hard Capsules


Tetralysal® 300 mg Hard Capsules
Read all of this leaflet carefully before you start taking this medicine.
- 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Tetralysal is and what it is used for
2. Before you take Tetralysal
3. How to take Tetralysal
4. Possible side effects
5. How to store Tetralysal
6. Further information

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.

2. Before you take Tetralysal
Do not take Tetralysal if:
• you are pregnant, planning to become pregnant or are breast-feeding
• you have ever had an allergic reaction to lymecycline, the active ingredient in this medicine or to other tetracycline antibiotics such as doxycycline or to any of the other
ingredients of Tetralysal (see section 6 for other ingredients). 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.
Take special care with 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) .
Taking 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.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking 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.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Tetralysal is not known to affect the ability to drive or use machines.

3. How to take Tetralysal
Always use Tetralysal exactly as your doctor has told you. The correct dose will be shown on the label which your pharmacist has placed on the container. You should 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
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.
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. 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 product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Tetralysal can cause side effects, although not everybody gets them.
Tetralysal may cause the following side effects.
Common side effects (occur in less than 1 in 10 patients)
- nausea (feeling sick)
- abdominal pain
- diarrhoea
- headache
Unknown frequency of occurrence (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.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Tetralysal
• Keep out of the reach and sight of children.
• Do not use Tetralysal 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.
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.

6. Further information


What Tetralysal contains
Tetralysal contains 408 mg of the active ingredient lymecycline (equivalent to 300 mg tetracycline base). 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.
This leaflet was last approved in 11/2009.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.