Pentacarinat 300 mg Powder for Solution for Injection/Infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your 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 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 your pharmacist.

1. What Pentacarinat powder is and what it is used for
2. Before you use Pentacarinat powder
3. How to use Pentacarinat powder
4. Possible side effects
5. How to store Pentacarinat powder
6. Further information

• You are allergic (hypersensitive) to pentamidine isetionate or any of the ingredients of this medicine (see Section 6: Further information).

Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of the lips, face, throat and tongue.

Do not have this medicine if the above applies to you.

Check with your doctor or your pharmacist before having this medicine if:

• You have liver or kidney problems.
• You have high or low blood pressure.
• You have a slow heartbeat (bradycardia), an uneven heartbeat or any other heart problems.
• You have a high or low blood sugar level.
• You have a low white blood cell count - signs include an unexplained infection or fever.
• You have anaemia (look pale or feel tired).
• You have unusual bruising or your blood takes a long time to clot.
• You have asthma, other breathing problems, or had a collapsed lung (pneumothorax) in the past.
• You smoke.
• You have unusual salt levels in your blood, especially if you have low levels of potassium (‘hypokalaemia’) or magnesium (‘hypomagnesaemia’).
  Blood tests will have shown this.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before having Pentacarinat 300mg.

If you have to go to a doctor, dentist or hospital for any reason, tell them that you are taking Pentacarinat powder. Also tell your doctor or pharmacist if you are taking or have recently taken any other medicine. This includes medicines you buy without a prescription, including herbal medicines. This is because Pentacarinat powder and some medicines can affect the way each other work.

In particular, tell your doctor if you are taking any of the following:

• Medicines for mood or thought problems called ‘phenothiazines’ (such as chlorpromazine and pericyazine).
• Medicines for depression called ‘tricyclic antidepressants’ (such as amitriptyline).
• Anti-histamines called terfenadine and astemizole - used for allergies.
• Antibiotics such as erythromycin or quinolones (includes ciprofloxacin).
• Halofantrine - used for malaria.
• Foscarnet - used for viral infections.

These medicines may cause an uneven heartbeat (seen on your ECG)called ‘QT prolongation’. Pentacarinat 300mg can increase the chance of this happening.

Before you are given Pentacarinat powder, your doctor will check your blood pressure, heart and blood.

Talk to your doctor before taking this medicine if:

• You are pregnant, plan to get pregnant, or think you may be pregnant.
  Miscarriage has been reported during the first three months of pregnancy.
• You are breast-feeding or planning to breast-feed.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

You may feel dizzy, tired, light headedness or faint or have muscle spasms and twitches whilst taking Pentacarinat powder. If this happens, do not drive or use any tools or machines.

• Pentacarinat powder will usually be given to you by a doctor or nurse at a clinic or in a hospital.
• It will be given either by injection or by inhalation using a nebuliser.
• If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor.

• A doctor or nurse will mix Pentacarinat powder with water for injections. If given into a vein, they will dilute it further in another liquid.
• You must lie down when you are given a Pentacarinat powder injection.
• Your doctor will decide how much to give you. The dose depends on your weight.

The usual dose of pentacarinat powder for adults, children and infants for the following illnesses is:

Lung Infection by PCP

• 4 mg for each kg of body weight, once each day for 14 days.
• If you have kidney problems, your doctor may give you this medicine less often.
• The dose is given by a slow infusion (drip) into a vein.

Infection of the skin by Leishmania

• 4 mg for each kg of your body weight, every other day for 3 doses.
• The dose is given by injection into your muscles or by a slow infusion (drip) into a vein.

Infection by Trypanosoma gambiense

Dose for adults, children and infants is:

• 4 mg for each kg of your body weight, once each day or for 7 days.
• The dose is given by injection into your muscles or by a slow infusion (drip) into a vein.

This medicine has been prescribed only for you.

• It is dangerous for other people to be exposed to this medicine
• This means that other people should not be in the same room when you are using the nebuliser.
  • The medicine is put in the nebuliser.
  • Air or oxygen is piped into the nebuliser.
  • This turns the medicine into a fine mist or spray.
  • This spray is then inhaled into your lungs.

To stop further attacks of Pneumocystis carinii Pneumonia (PCP)

Dose for adults only is:

• Inhalation of the spray from 1 bottle every 4 weeks.

Or

• Inhalation of half a bottle every 2 weeks.

If you have too much of this medicine, talk to doctor or go to a hospital straight away. Too much Pentacarinat powder can cause problems with your heart.

Contact your doctor straight away to arrange another appointment as soon as possible.

Do not stop having your medicine without talking to your doctor. You should not stop having Pentacarinat Powder just because you feel better. This is because the infection may come back again or get worse.

• If you have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
• If you have severe skin reactions. Signs include blistering or bleeding of the skin around the lips, eyes, mouth, nose and genitals. Also flulike symptoms and fever. This may be something called ‘Stevens- Johnson syndrome’.
• Low blood pressure (hypotension). Signs include feeling dizzy, lightheaded or fainting.
• Low blood sugar level (hypoglycaemia). Signs include feeling nervous, shaky or sweaty.
• Low numbers of white cells in your blood (leucopenia) - signs include an unexplained infection or fever.
• You bruise or bleed more easily than usual. This could be because of a blood disorder (thrombocytopenia).
• Kidney failure - changes in the way your kidneys are working. These would show up in the results of some blood or urine tests. You may also notice signs such as swollen ankles, passing less water (urine) than usual, low back pain.
• If you have low levels of calcium in your blood (‘hypocalcaemia’).
• Inflammation of the pancreas (pancreatitis). Signs include severe stomach pain - which may reach through to the back.
• Uneven or fast heart beat.

• Yellowing of the skin and eyes.
• Flushing or fainting.
• Feeling dizzy, tired or faint. This may be due to low blood pressure when standing up.
• Chest pain, cough, wheezing, shortness of breath or difficulty breathing.
• Feeling sick (nausea), being sick (vomiting) or stomach pain.
• Blood in your urine.
• Muscle spasm, muscle twitch or pins and needles.
• Pain, or a lump or abscess at the site where you were given the injection.
• Rash.
• Increased thirst or needing to go to the toilet more often.
• Change in the way things taste or a loss of appetite.
• Fever.
• Unexplained muscle pain, tenderness or weakness.
• Tingling or numbness in hands and feet.
• Reduced sensation or numbness around the mouth.
• Slow heartbeat.

Tell your doctor straight away if you notice any side effects not listed in this leaflet.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

• Each small glass bottle (vial) contains 300mg the active substance, Pentamidine isetionate (equivalent to 172.4 mg pentamidine base).

Pentacarinat powder is a white or almost white plug of lyophilised powder contained in a glass vial. Pentacarinat powder is supplied in cartons containing 5 glass vials. Each vial contains a single dose of Pentacarinat powder for solution for injection/infusion.

Marketing Authorisation Holder

Manufacturer

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.