Lymecycline 408mg Capsules
200 mm
KinedexE
PACKAGE LEAFLET: INFORMATION FOR THE USER
LYMECYCLINE 408MG CAPSULES
lymecycline (equivalent to 300mg tetracycline base)
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READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Lymecyline is and what it is used for.
2. Before you take Lymecycline
3. How to take Lymecycline
4. Possible side effects
5. How to store Lymecycline
6. Further Information
1. WHAT LYMECYCLINE IS AND WHAT IT IS USED
FOR?_
Lymecycline belongs to a group of medicines called tetracycline antibiotics.
The main use of Lymecycline is the treatment of moderate to severe acne. Acne appears as blackheads and whiteheads which people often refer to as pimples or spots. Lymecycline attacks the bacteria that are one of the main causes of acne. The name of these bacteria is propionibacterium acnes.
If you are not sure why you have been prescribed this medicine, talk to your doctor.
2. BEFORE YOU TAKE LYMECYCLINE_
Do not take Lymecycline 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 Lymecycline (see section 6 for other ingredients). An allergic reaction may include either a rash or itching
- you have ever had kidney disease
Lymecycline must not be given to children under 12 years of age.
Lymecycline must not be taken at the same time as medicines which contain oral retinoids (these include some other medicines used to treat acne).
Take special care with Lymecycline
Tell your doctor before taking Lymecycline if you
- have ever had a liver or kidney 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)
- have ever developed rashes in response to exposure to sun-light or tanning lamps.
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 including roaccutane.
Do not take the following medicines at the same time as your Lymecycline as these could affect how well your acne medicine works. Wait at least two to three hours after taking Lymecycline 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
- didanosine for HIV infection.
If you take a contraceptive pill, it may not work properly while you are taking Lymecycline, 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 was included 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 Lymecycline with food and drink
Absorption of Lymecycline is not affected by moderate amounts of milk. Lymecycline capsules should always be taken with a glass of water.
Pregnancy and breast-feeding
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.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Lymecycline is not known to affect the ability to drive or use machines.
3. HOW TO TAKE LYMECYCLINE_
Always use Lymecycline 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.
Adults and children over12 years Moderate to severe acne
The normal dose is one Lymecycline capsule once a day, preferably in the morning.
How long you will have to take Lymecycline for will depend on how quickly your condition improves. For acne, this will normally be at least 8 to 12 weeks. Your physician may decide to continue with treatment for a maximum of 6 months.
Lymecycline capsules should always be taken with a glass of water. They should also be taken with a light meal without dairy products.
Kidney impairment:
If you have a kidney problem your doctor may decide to reduce your dose.
Pharma Code
Do not give Lymecycline to children below the age of 12 years, it could harm them.
If you take more Lymecycline than you should
If you, or anyone else, take too many Lymecycline 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 Lymecycline
If you forget to take a dose, simply take it when you remember and carry on as before unless it is time for the next dose. Do not take a double dose of capsules to make up for a missed dose. You should never take more capsules than your doctor recommends.
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 product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS_
Like all medicines, Lymecycline can cause side effects although not everybody gets them.
Lymecycline 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 tongue1
- blistering or peeling of large areas of the skin1
- ulcerations or lesions on the mouth, lips, genital or anal regions1
- 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 Lymecycline 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 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, severe nausea, or any visual disturbance.
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.
5. HOW TO STORE LYMECYCLINE_
• Keep out of the reach and sight of children.
• Do not use Lymecycline after the expiry date, which is stated on the carton and blister label. The expiry date refers to the last day of the 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 Lymecycline contains?
Each Lymecycline capsule contains 408 mg of the active ingredient lymecycline (equivalent to 300 mg tetracycline base). The other ingredients are magnesium stearate, colloidal hydrate silica. The capsule shells contain gelatin, titanium dioxide (E171), erythrosine (E127), quinoline yellow (E104) and indigotine (E132), the ink contains potassium hydroxide, black iron oxide (E172), propylene glycol and shellac.
What Lymecycline looks like and contents of the pack
Lymecycline capsules are hard gelatin capsules with yellow body and red cap imprinted with NM. Lymecycline capsules are packed in a carton containing 28 or 56 capsules packed in blisters. Each blister strip contains 4 capsules and there are 7 or 14 blister strips in each carton. Not all pack sizes may be marketed.
Marketing Authorisation Holder
The marketing authorisation holder of this medicine is KINEDEXE UK Limited, Unit 15 Moorcroft, Harlington Road, Uxbridge, UB8 3HD, United Kingdom.
Manufacturer
Lime Pharma Limited, Unit 15 Moorcroft, Harlington Road, Hillingdon, UB8 3HD, United Kingdom.
This leaflet was approved in 07/2015
Tell your doctor immediately if you develop side effects such as swollen face, lips, tongue and throat, difficulty