Lymecycline 408mg hard capsules

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.

The name of your medicine is Lymecycline 408mg hard capsules but will be referred to as Lymecycline throughout this leaflet.

What is in this leaflet

Q What Lymecycline is and what it is used for 0 What you need to know before you take Lymecycline Q How to take Lymecycline Q Possible side effects Q How to store Lymecycline Q Conte nts of the pack and other information

Q What Lymecycline is and what it is used for

Lymecycline belongs to a group of medicines called tetracycline antibiotics.

It is used to treat acne; which appears as blackheads and whiteheads which people often refer to as pimples or spots.

This medicine can also be used to treat other infections such as

•    Acute sinusitis

•    Bronchitis

•    Infections in the abdomen

•    Chlamydia

•    Some types of eye infections called trachoma

•    Rickettsial fever

•    Soft tissue infections.

Q What you need to know before you take Lymecycline

Do not take Lymecycline if you:

•    are allergic to lymecycline, any other tetracyclines or any of the other ingredients of this medicine (listed in section 6)

•    have ever had kidney disease

•    are a child under the age of 12 years

•    are pregnant or breast-feeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking Lymecycline if you:

•    have had liver problems

•    have had kidney problems

•    suffer from systemic lupus erythematosus (an allergic condition that causes joint pain, skin rashes or fever)

•    suffer from Myasthenia Gravis (a disease that weakens the muscles).

You should avoid direct exposure to sunlight or artificial sunlight from sunbeds. If you experience skin discomfort then stop taking this medicine and seek advice from your doctor.

Children and adolescents

Lymecycline is not recommended for use in children under 12 years of age as it can cause permanent discolouration of tooth enamel and affect bone development.

Other medicines and Lymecycline

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

Do not take the following medicines at the same time as Lymecycline, take them at least two hours before Lymecycline or two hours after:

•    indigestion remedies

•    ulcer healing drugs

•    quinapril (for high blood pressure)

•    supplements containing calcium, aluminium, magnesium, zinc or iron.

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

•    oral retinoids (to treat acne)

•    anticoagulants (to stop the blood clotting)

•    diuretics (used to treat kidney disease, heart disease or high blood pressure)

•    medicines for epilepsy including barbiturates e.g. phenobarbitone, phenytoin and carbamazepine

•    methoxyflurane (an anaesthetic).

Lymecycline with food and drink

Absorption of Lymecycline is not affected by moderate amounts of milk (e.g. a glass). Lymecycline should always be taken with a glass of water.

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.

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

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

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed.

Q How to take Lymecycline

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults and children over 12 years

Acne

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

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

Infections

For other infections, the usual dosage is one Lymecycline 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.

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

Use in children under 12 years

Lymecycline is not recommended for use in children under 12 years of age as it can cause permanent discolouration of tooth enamel and affect bone development.

If you take more Lymecycline than you should

If you (or someone else) takes too many capsules, or you think a child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately.

If you forget to take Lymecycline

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time.

If you stop taking Lymecycline

Acne responds slowly to antibiotics. It is important that you take all the Lymecycline that your doctor has prescribed for you. If you stop taking Lymecycline 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.

TlPossi ble side effects

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

If you experience any of the following serious side effects, stop taking your capsules and tell your doctor immediately or go to the nearest hospital accident and emergency department.

Unknown frequency of occurrence (frequency cannot be estimated from the available data):

•    Serious allergic reaction which causes swelling ofthe face, tongue and throat that can cause great difficulty in breathing.

•    Serious illness with severe peeling and swelling ofthe skin, blistering of the skin, mouth, eyes genitals and fever. Skin rash with pink-red blotches especially on palms of hands or soles of feet which may blister.

Lymecycline may also 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)

•    disturbances of eyesight

•    dizziness

•    vomiting (being sick)

•    yellowing ofthe skin or eyes (jaundice)

•    increased sensitivity ofthe 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 Lymecycline belongs (the tetracyclines):

•    inflammation or ulceration ofthe 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 ofthe genital area

•    yeast infection around the anus or genitals

•    infection of the colon

•    permanent visual loss.

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects, you can help provide more information on the safety of this medicine.

Tl How to store Lymecycline

•    Keep out ofthe sight and reach of children.

•    Do not store above 25°C.

•    Store in the original package in order to protect from light.

•    Do not take Lymecycline after the expiry date which is stated on the carton and blister label after 'Exp'. The expiry date refers to the last day of that month.

•    If the capsules become discoloured or show any signs of deterioration, seek the advice of your pharmacist.

•    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.

j] Contents of the pack and other information

What Lymecycline contains

The active substance is lymecycline.

Each capsule contains 408mg of lymecycline equivalent to 300mg tetracycline base.

The other ingredients are colloidal hydrated silica, magnesium stearate, capsule body: titanium dioxide (E171), gelatine, capsule cap: indigo carmine (E132), black iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172), gelatine.

What Lymecycline looks like and contents of the pack

Lymicycline is hard gelatin capsule with a blue cap and white body.

Lymicycline is available in blister strips containing 28 capsules.

Manufactured by: Actavis Group ehf, Reykjavikurvegur 78, 220 Hafnarfjordur, Iceland.

Procured from within the EU and repackaged by the Product License holder: B&S Healthcare, Unit 4,

Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.

Lymecycline 408mg hard capsules;

PL 18799/2873    POM

Leaflet date: 12.09.2016