LINDACIL capsules contains the active substance Clindamycin hydrochloride which belongs to an antibiotic group called Lincosamide used in the treatment of serious bacterial infections.

Do not take LINDACIL

If you are allergic (hypersensitive) to Clindamycin, lincomycin or to any of the other ingredients in this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before using LINDACIL if:

• You have diarrhea or usually get diarrhea when you take antibiotics or have ever suffered from problems with your stomach or intestines. If you develop severe or prolonged or bloody diarrhea during or after using LINDACIL tell your doctor immediately since it may be necessary to interrupt the treatment. This may be a sign of bowel inflammation (pseudomembranous colitis) which can occur following treatment with antibiotics.

• You suffer from problems with your kidneys or liver.

• You suffer from asthma, eczema or hay fever.

• You develop any severe skin reactions or hypersensitivity to LINDACIL.

Other medicines and LINDACIL

Tell your doctor or pharmacist or nurse if you are taking, have recently taken or might take any other medicines including those obtained without a prescription:

• Muscle relaxants used for operations (neuromuscular blockers).

• Oral contraceptive pills. You should use extra contraception such as condoms whilst taking LINDACIL and for seven days after taking LINDACIL.

• Warfarin or similar medicines – used to thin the blood. You may be more likely to have a bleed. Your doctor may need to take regular blood tests to check how well your blood can clot.

• CYP3A4 or CYP3A5 inducers like rifampicin may impact effectiveness of the medicine.

Pregnancy and breast-feeding

Pregnancy

If you are pregnant or think you might be pregnant you should contact your doctor before taking LINDACIL.

Ask your doctor or pharmacist for advice before taking any medicine.

Breast-feeding

Tell your doctor if you will be breast-feeding while taking LINDACIL as Clindamycin may be passed into breast milk. Your doctor will decide if LINDACIL is appropriate for you. If you continue to take LINDACIL, you should stop breast-feeding.

Driving and using machines

No effects on the ability to drive or use machines have been seen with LINDACIL.

LINDACIL Capsules contain lactose

LINDACIL Capsules contains lactose a type of sugar. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

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

LINDACIL Capsules should always be swallowed whole with a full glass of water.

Adults and Elderly Patients

The recommended dose of LINDACIL is between 150 and 450mg (1 to 3 capsules) every 6 hours, depending on the severity of your infection.

Use in children

This medicine is used for children who are able to swallow capsules. The recommended dose in children is between 12 and 25 mg / kg /day of bodyweight, divided into six hourly doses, depending on the severity of the infection. Your doctor will work out the number of capsules that your child should have. If your child is unable to swallow capsules, talk to your doctor or pharmacist.

Long term use of LINDACIL

If you have to take LINDACIL for a long time, your doctor may arrange regular liver, kidney and blood tests. Do not miss these check-ups with your doctor.

Long term use can also make you more likely to get other infections that do not respond to LINDACIL treatment.

If you take more LINDACIL Capsules than you should

If you accidentally take too many LINDACIL Capsules contact your doctor at once or go to the nearest hospital casualty department. Always take the labelled medicine package with you, whether there are any LINDACIL Capsules left or not. Do not take any more capsules until your doctor tells you to.

If you forget to take LINDACIL

If the forgotten dose is just a few hours late, use it straight away. If it is nearly time for your next dose miss out the forgotten one. Do not take a double dose to make up for a missed dose.

If you stop taking LINDACIL

If you stop taking the medicine too soon your infection may come back again or get worse.

Do not stop taking LINDACIL unless your doctor tells you to.

If you have any further questions on how to take this product, ask your doctor or pharmacist.

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

Tell your doctor immediately if you develop:

• Severe, persistent or bloody diarrhea (which may be associated with stomach pain or fever). This is an uncommon side effect which may occur during or after completing treatment with antibiotics and can be a sign of serious bowel inflammation or pseudomembranous colitis.

• Signs of a severe allergic reaction such as sudden wheeziness, difficulty in breathing, dizziness, swelling of the eyelids, face, lips, throat or tongue, rash or itching (especially affecting the whole body).

• Blistering and peeling of large areas of skin, fever, cough, feeling unwell and swelling of the gums, tongue or lips.

• Yellowing of the skin and whites of the eyes (jaundice).

• Potentially life threatening skin rashes:

- Widespread rash with blistering and peeling of large areas of skin, particularly around the mouth, nose, eyes or genitals, known as Stevens-Johnson syndrome, or a more severe form with extensive peeling of the skin (more than 30% of the body surface) known as toxic epidermal necrolysis

- Rare skin eruption that is characterised by the rapid appearance of areas of red skin studded with small pustules (small blisters filled with white/yellow fluid) (Acute Generalised Exanthematous Pustulosis (AGEP)

- Skin rash, which may blister, and looks like central dark spots surrounded by a paler area, with a dark ring around the edge

- erythema multiforme   

- Widespread red skin rash with small pus-containing blisters (bullous exfoliative dermatitis)

- Fever, swollen lymph nodes or skin rash, these may be symptoms of a condition known as DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms) and can be severe and life-threatening.

Other possible side effects may include:

Common (may affect up to 1 in 10 people):

· Abnormal liver function tests (poor liver function).

· Pain in stomach / abdomen, diarrhea.

Uncommon (may affect up to 1 in 100 people)

· Feeling sick or being sick.

· Rash- characterized by a flat red area on the skin that is covered with small bumps and hives.

Frequency cannot be estimated from the available data:

· Infection inside and around the vagina.

· Inflammation of the large intestine which causes abdominal pain, fever or diarrhea due to infection by Clostridioides difficile.

· Effects on your blood system: reduced numbers of blood cells which may cause bruising or bleeding or weaken the immune system.

· Changes in the way things taste.

· Inflammation of the lining of the oesophagus (gullet), open sores or lesions in the lining of the oesophagus (gullet).

· Yellowing of the skin and whites of the eyes (jaundice).

· Red or scaly skin (exfoliative dermatitis), red measles-like rash (rash morbilliform), itching.

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.

• Keep this medicine out of the sight and reach of children.

• Do not use LINDACIL Capsules after the expiry date which is stated on the carton and blister labels. The expiry date refers to the last day of that month.

• Do not store above 30°C.

• 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 to protect the environment.