Lymecycline Activo 300 mg Capsules

LYMECYCLINE ACTIVO belongs to a group of medicines known as tetracycline antibiotics. LYMECYCLINE ACTIVO is used to treat infections caused by suspectable bacteria in certain conditions, such as:

• Upper and lower respiratory tract infections, such as bronchitis and sinusitis.
• Urinary tract infections and sexually transmitted diseases.
• Soft tissue infections, like acne.
• Eye infections.
• Infections of the stomach.

LYMECYCLINE ACTIVO can also be used to treat other infections caused by suspectable bacteria.

Do not take LYMECYCLINE ACTIVO:

• if you are hypersensitive (allergic) to lymecycline, to other tetracycline antibiotics (such as doxycycline, minocycline, tetracycline, oxytetracycline) or any of the other ingredients of LYMECYCLINE ACTIVO (listed in section 6).
• if you have, or ever had, kidney disease or impaired kidney function.
• if you have been diagnosed with systemic lupus erythematosus (an allergic condition that causes joint pain, skin rashes or fever). LYMECYCLINE ACTIVO may worsen this condition.
• if you are taking a medicine that contains oral retinoids (for example, isotretinoin and vitamin A) which can also be used to treat acne (see section 2: “ Other medicines and LYMECYCLINE ACTIVO ” below).
• if you are pregnant, planning to have a baby or breastfeeding your baby (see section 2: “ Pregnancy, breastfeeding and fertility ”).

LYMECYCLINE ACTIVO should not be given to children under the age of 12 years. It is known to cause permanent teeth discolouration, thinning of the tooth enamel and affects bone development.

Warnings and precautions

Tell your doctor before taking LYMECYCLINE ACTIVO:

• if you have impaired liver function (liver disease), especially if you are over the age of 65 years.
• if you have been diagnosed with myasthenia gravis (a disease that weakens the muscles), because LYMECYCLINE ACTIVO may worsen this condition.

The prolonged use of LYMECYCLINE ACTIVO may result in opportunistic infections. This is an infection that may occur when the immune system is weakened. This includes yeast infections, such as oral thrush and vaginal thrush, and bacterial infections that may cause diarrhoea (see section 4: “ Possible side effects ”).

You should avoid direct exposure to sunlight and artificial light from sunbeds due to the risk of photosensitivity (skin discomfort experienced when exposed to direct sunlight or artificial sunlight from sunbeds). If you experience skin discomfort, stop taking LYMECYCLINE ACTIVO and contact your health care provider.

Taking too much LYMECYCLINE ACTIVO (i.e., taking more than the recommended dose) may cause liver problems.

Do not use expired LYMECYCLINE ACTIVO. This may cause a Fanconi-type syndrome, which is a serious kidney disease. The signs and symptoms of this condition are excessive thirst and urination, nausea and vomiting. The expiry date can be found on the blister packaging and the outer carton.

You may develop vitamin deficiencies when using LYMECYCLINE ACTIVO for prolonged periods. Your doctor may advise you to use a vitamin supplement.

Take LYMECYCLINE ACTIVO with adequate amounts of water to prevent lodging in the throat. This is to prevent pain, irritation and sores in the throat.

Do not share medicines prescribed for you with any other person. Always take LYMECYCLINE ACTIVO exactly as your doctor or pharmacist has instructed you. You should check with your doctor or pharmacist if you are unsure.

Acne:

The usual dose is one (1) LYMECYCLINE ACTIVO capsule once a day, usually for 12 weeks.

Infections:

The usual dose is one (1) LYMECYCLINE ACTIVO capsule every 12 hours. Your doctor may recommend a lower or higher dose depending on the severity and type of infection.

Take LYMECYCLINE ACTIVO one hour before or two hours after a meal. LYMECYCLINE ACTIVO should be taken with a sufficient amount of water to prevent lodging in the throat. This is to prevent pain, irritation and sores in the throat.

Elderly: No dosage adjustment is required if you are 65 years of age or older. Your doctor will tell you how long your treatment with LYMECYCLINE ACTIVO will last. Do not stop treatment early because your infection will not be treated properly.

If you have the impression that the effect of LYMECYCLINE ACTIVO is too strong or too weak, tell your doctor or pharmacist.

Use in Children

Do not give LYMECYCLINE ACTIVO to children below the age of 12, it could harm them. It is known to cause permanent discolouration and thinning of the teeth and affects bone development.

If you take more LYMECYCLINE ACTIVO than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Take the medicine with you. This could indicate how many capsules have been taken.

If you forget to take LYMECYCLINE ACTIVO

Always take LYMECYCLINE ACTIVO as prescribed (see “ How to take LYMECYCLINE ACTIVO ”). If you have missed a dose, take it as soon as you remember. Do not take a double dose of LYMECYCLINE ACTIVO to make up for forgotten individual doses.

If you stop taking LYMECYCLINE ACTIVO

Your doctor will tell you how long your treatment with LYMECYCLINE ACTIVO will last. Do not stop treatment even if you are feeling well unless your doctor tells you. Acne responds slowly to antibiotics. If you stop taking LYMECYCLINE ACTIVO too soon, your acne or infection could get worse or come back.

LYMECYCLINE ACTIVO may have side effects. Not all side effects reported for LYMECYCLINE ACTIVO are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this medicine, please consult your doctor, pharmacist or other health care provider for advice.

If any of the following happens, stop taking LYMECYCLINE ACTIVO and tell your doctor immediately or go to the casualty department at your nearest hospital:

• 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; or
• yellowing of the skin and eyes (jaundice), dark urine and tiredness which may be symptoms of liver problems.

These are all very serious side effects. If you have them, you may have had a serious reaction to or side effect from LYMECYCLINE ACTIVO. You may need urgent medical attention or hospitalisation.

Benign intracranial hypertension has been reported in general with tetracycline therapy. Symptoms may include:

• headache;
• vomiting;
• visual disturbances (blurred vision, blind spots or double vision); or
• permanent visual loss.

If you notice any of the above, stop taking LYMECYCLINE ACTIVO and tell your doctor immediately or go to the casualty department at your nearest hospital. You may need urgent medical attention.

The following side effects are frequently experienced with the use of LYMECYCLINE ACTIVO:

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

Other side effects with an unknown frequency associated with the use of LYMECYCLINE ACTIVO include:

• changes in the number or type of certain blood cells including red blood cells, white blood cells and/or platelets.
• depression and nightmares.
• disturbances of eyesight and dizziness.
• pain in the upper abdomen, vomiting (being sick) and inflammation of the intestines.
• inflammation of the tongue (which may present as swelling, redness or tenderness of the tongue).
• itching, skin rash or hives and increased sensitivity of the skin to sunlight.
• nail discolouration, loosening of the nail from the fingers and/or toes.
• fever.
• changes in some blood tests (tests of liver function).

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

• systemic lupus erythematosus (an allergic condition that causes joint pain, skin rashes or fever).
• inflammation or ulceration of the gullet, causing pain or difficulty swallowing or painful heartburn.
• difficulty in swallowing.
• inflammation of the pancreas or liver, or liver damage.
• teeth discolouration.
• inflammation or soreness of the tongue, mouth, cheeks, gums or lips.
• soreness or itching of the genital area or yeast infection around the anus or genitals.
• inflammation and infection of the colon causing diarrhea.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get 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 to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on the SAHPRA website. By reporting side effects, you can help provide more information on the safety of LYMECYCLINE ACTIVO.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

Store at or below 25 °C.

Store in the original packaging.

Do not take LYMECYCLINE ACTIVO after the expiry date stated on the blister strips or carton. Return all unused LYMECYCLINE ACTIVO to your pharmacist. Do not dispose of unused tablets in drains or sewerage systems (e.g., toilets).