Cilapen Injection

CILAPEN 500 belongs to a group of medicines called thienamycins. It kills a wide range of bacteria (germs) that cause infections in various parts of the body.

CILAPEN 500 is used for the treatment of several bacterial infections, except meningitis.

You should not receive CILAPEN 500:

• if you have had an allergic reaction to imipenem and cilastatin or similar antibiotics (including penicillin or cephalosporin) or to any of the ingredients (listed in section 6). (An allergic reaction may include rash, itching, swelling of face/lips/tongue/hands/feet or breathing difficulties.)
• if you are pregnant or planning to become pregnant or breastfeeding.
• if you are suffering from meningitis (which is inflammation of the membranes surrounding the brain and spinal cord).

Please inform your doctor, even if these statements were applicable to you at any time in the past.

Warnings and precautions

Tell your doctor or healthcare provider before being given CILAPEN 500:

• if you had history of convulsions (fits) in past.
• if you are have had kidney problems.
• if you have severe diarrhoea (which may contain blood or mucous) along with stomach cramps (symptoms of a condition known as pseudomembranous colitis).
• if you have liver problems.
• if you have a serious allergic reaction that could lead to heart problems.

You may develop a positive test (Coombs test) which indicates the presence of antibodies that may destroy red blood cells. Your doctor will discuss this with you.

An injection will be administered into a vein (intravenous injection) by a healthcare provider. The number of injections you require will depend upon your condition.

If you receive more CILAPEN 500 than you should

Since a healthcare provider will administer CILAPEN 500, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you do not receive CILAPEN 500

Since a healthcare provider will administer CILAPEN 500, it is unlikely that the dose will be missed.

CILAPEN 500 may cause side effects. Not all side effects reported for CILAPEN 500 are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving CILAPEN 500, please consult your healthcare provider for advice.

If any of the following happens your healthcare provider will stop CILAPEN 500 immediately:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• blistering and/or peeling of the skin,
• fainting.

These are very serious side effects. If you have them you may have had a serious allergic reaction or other type of reaction to CILAPEN 500 and you may need urgent medical attention.

Tell your doctor immediately if you notice any of the following:

• severe diarrhoea (which may contain blood or mucous) along with stomach cramps,
• bleeding or increased tendency to bleed, persistent sore throat and frequent infections, and/or anaemia, fever,
• myoclonic activity (shock - like contractions of a portion of a muscle, an entire muscle or a group of muscles restricted to one area of the body or in several areas),
• hallucinations and confusion, memory loss,
• convulsions (fits),
• worsening of a rare disease associated with muscle weakness,
• loss of hearing,
• bluish discoloration of the face and lips,
• irregular heartbeat, the heart beating forcefully or rapidly,
• swelling and redness along a vein which is extremely tender when touched,
• difficulty breathing, abnormally fast and superficial breathing,
• yellowing of skin and whites of eyes, dark urine, and tiredness which may be symptoms of liver problems,
• swelling of face, ankles or other parts of the body, with sudden increase or decrease in the amount of urine passed, or blood in the urine, changes in urine colour.

Tell your doctor if you notice any of the following:

Frequent side effects:

• nausea or vomiting,

Less frequent side effects:

• fungal infection,
• dizziness, increased sleepiness,
• pins and needle sensations of toes and fingers, tremors, taste disturbance, headache,
• ringing in the ears,
• low blood pressure, reddening of the skin,
• sore throat,
• staining of teeth and tongue, stomach pain, heartburn, red swollen tongue, overgrowth of the normal projections on the tongue giving it a hairy appearance, increase in the production of saliva,
• excessive sweating, changes in the texture of the skin,
• pain in the joints, pain in the upper spine,
• itching of the skin just outside the vagina in women,
• fever,
• redness, itching, swelling and pain at the site of injection, chest discomfort, weakness,

Side effects with unknown frequency:

• agitation,
• uncontrolled, involuntary muscle movement.
• Chest pain in the context of allergic reactions, which may be a symptom of allergy triggered cardiac infarction (Kounis syndrome)

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 or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of CILAPEN 500.

• Store all medicines out of reach of children.
• Store the dry powder below 25 °C and protect from light. Protect from freezing.
• The container must be stored in the carton until required for use. After reconstitution, the solution may be kept for 4 hours at 25 °C or for 24 hours under refrigeration (4 °C). The product is for single use only and any unused portion must be discarded.
• Do not use after the expiry date stated on the label.
• Return all unused medicines to your pharmacist.
• Do not dispose of unused medicines in drains or sewerage systems e.g. toilets.