Famucaps, hard Capsules

FAMUCAPS contains the following active ingredients: chlorphenamine maleate, phenylephrine hydrochloride and paracetamol.

FAMUCAPS is used for the symptomatic relief of:

• Sinusitis (feeling of tension or fullness in the nose, cheeks and behind your eyes, sometimes with a throbbing ache).
• Rhinitis (runny nose) and allergic conditions of the respiratory tract.
• Hay fever and influenza (flu-like symptoms).

Do not take FAMUCAPS:

• If you are hypersensitive (allergic) to chlorphenamine maleate, phenylephrine hydrochloride, paracetamol or any of the other ingredients of FAMUCAPS (listed in section 6).
• If you have kidney problems.
• If you are pregnant or breastfeeding your baby.
• If you have any disease that affects your heart.
• If you suffer from epilepsy (fits or seizures).
• If you suffer from high blood pressure.
• If you suffer from an overactive thyroid gland.
• If you suffer from a tumour of the adrenal gland, which is located near the kidney (phaeochromocytoma).
• If you have abnormally high pressure in your eye (glaucoma).
• If you are taking other medicine used to treat a cold or flu.
• If you are taking tricyclic antidepressants, used to treat depression.
• If you are taking beta blocking medicines, used to reduce blood pressure.
• If you are receiving a monoamine oxidase inhibitor (antidepressant treatment), or if you stopped this treatment less than 10 days ago.
• If your child is younger than 6 years.
• If you have liver problems or are an alcoholic.
• If you suffer from diabetes mellitus, as you may experience an increase in your blood sugar levels.

Warnings and precautions

FAMUCAPS contains paracetamol which may be fatal in overdose. In the event of overdose or suspected overdose, even if the person does not show any symptoms of overdose, the nearest doctor, hospital or poison centre must be contacted immediately. Doses higher than the recommended dose can damage your liver.

Take special care with FAMUCAPS:

• If you have liver or kidney problems, paracetamol must be taken under supervision of your doctor.
• Do not use in combination with any other medicines containing paracetamol as it may lead to an overdose. Paracetamol overdose may cause liver failure, which may require liver transplant and may lead to death.
• Do not use in combination with other medicines that may cause sedation, as this may lead to an increase in sedative effects.
• If your prostate gland is enlarged (prostate hypertrophy).
• If you suffer from any respiratory disorder (bronchitis, bronchiectasis (coughing up thickened mucus and shortness of breath), emphysema (shortness of breath, with a cough) or asthma (difficulty breathing, chest pain, cough and wheezing)).
• If you have a condition called porphyria.
• If you have low levels of glutathione due to metabolic deficiencies.
• If you have any disease that affects your blood vessels.
• If you are unusually or excessively excitable (increased energy, restlessness and nervousness).
• If you are an elderly patient and may sometimes be confused.
• If you have problems to empty your bladder completely (urinary retention).
• If you have problems with your gastric outflow (pyloroduodenal obstruction).
• If you have not received any relief from your symptoms with the recommended dosage for more than 10 days.

DO NOT EXCEED THE RECOMMENDED DOSE.

Adults: 2 capsules 3 times a day.

Children (6 – 12 years): 1 capsule 3 times a day.

Not recommended for children younger than 6 years.

Do not use continuously for more than 10 days without consulting your doctor.

If you take more FAMUCAPS than you should

Prompt treatment is essential. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. A delay in starting treatment may mean that the antidote is given too late to be effective.

FAMUCAPS contains paracetamol, which is very harmful when taken in high amounts.

If you forget to take FAMUCAPS

If you or your child forget to take a dose, take it as soon as you remember. Do not take a double or larger dose to make up for the forgotten individual doses. Continue to take the next dose at the usual time.

FAMUCAPS can have side effects. Not all side effects reported for FAMUCAPS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking FAMUCAPS, please consult your health care provider for advice.

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

• Swelling of your hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in breathing or swallowing.
• Rash, itching.
• Fainting.

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

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Tightness of your chest, difficulty breathing, shortness of breath.
• Seizures (fits).
• Cerebral haemorrhage (an emergency condition in which a ruptured blood vessel causes bleeding inside the brain, which may be characterised by a sudden tingling, numbness or paralysis of the face, arm or leg, particularly on one side of the body, confusion, dizziness, visual disturbances, difficulty walking or speaking).
• Frequent infections, such as fever, severe chills, sore throat or mouth ulcers.
• Bleeding or bruising more easily than normal.
• Tiredness, headaches, being short of breath when exercising, dizziness, looking pale.
• Palpitations (the sensation that your heart has skipped a beat or added an extra beat), irregular heartbeat, fast heartbeat (tachycardia).
• Chest pain (angina), a sudden, unexpected loss of heart function, decreased heart rate (bradycardia).
• Build-up of fluid in the lungs characterised by breathlessness, which may be severe and usually worsens when laying down.
• Kidney problems (build-up of fluid in your body causing swelling in your legs, ankles or feet, difficulty to urinate, lower back pain).
• Liver problems (with yellowing of your skin or eyes and dark coloured urine).

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to FAMUCAPS. You may need urgent medical attention.

Tell your doctor as soon as possible if you notice any of the following:

• Nervousness.
• Headache, dizziness, inability to sleep.
• Nausea, vomiting, diarrhoea.
• Sleepiness, drowsiness, difficulty to concentrate.
• High blood pressure.

Frequency unknown:

• Reduced or loss of appetite.
• Change in metabolism including a change in the sugar (glucose) levels in your blood.
• Anxiety, fear, restlessness, confusion, psychiatric disorders, irritability, hallucinations.
• Shaking or tremors.
• Flushing.
• Difficulty passing urine or emptying your bladder.
• Painful urination.
• Blurred vision.
• Buzzing or ringing sound in your ears.
• Low blood pressure (dizziness or light-headedness).
• Thickened respiratory tract secretions (mucus).
• Dry mouth, stomach pain, constipation, heartburn.
• Increased sensitivity of your skin to sunlight.
• Muscle spasm, unusual muscle tone causing distortion of the body, unsteadiness when walking, muscle weakness.
• Fatigue, medicine-induced fever, dryness of the nose.
• Inflammation of the pancreas.
• Stomach pain caused by kidney stones (renal colic).
• High levels of white blood cells in your urine (pyuria).
• Dilated pupils, build-up of pressure in your eye (acute angle-closure glaucoma).
• Depressed or elevated mood, nightmares.
• Increased energy, particularly in children.
• Weakness.

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. 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 FAMUCAPS.

Store at or below 25 °C. Protect from moisture.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).