Amderip Film-Coated Tablets

AMDERIP belongs to a group called tricyclic antidepressants and contains amitryiptyline hydrochloride. AMDERIP is used to treat the symptoms of depression in patients 18 years and older.

Do not take AMDERIP:

• If you are allergic (hypersensitive) to amitriptyline hydrochloride or any of the other ingredients of AMDERIP (listed in section 6),
• if you recently had a heart attack,
• if you have heart disease, heart failure or irregular heartbeats,
• if you are taking monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within the last 14 days, such as selegiline,
• if you are taking linezolid which is an antibiotic,
• if you are taking medicines for the treatment high blood pressure, such as amlodipine, nifedipine,
• if you are pregnant, intend to become pregnant or if you are breastfeeding your baby,
• if the child is under the age of 18,
• if you have periods of increased or exaggerated behaviour (mania),
• if you have severe liver disease.

Warnings and precautions

Special care should be taken with AMDERIP:

• If you experience dry mouth, constipation, difficulty urinating and blurred vision or vision problems, you should consult your doctor.
• If you have drowsiness, agitation, restlessness, difficulty sleeping (insomnia) and restlessness.
• If you have high blood pressure (hypertension) or a heart condition/disorder.
• If you have high blood sugar levels (diabetes).
• If you experience changes in your sex drive (libido), interference with sexual function, swelling of breasts in women, breast swelling in men (gynaecomastia) and flow of milk from breast when not breastfeeding (galactorrhoea).
• If you have a psychiatric disorder (depression or mania).
• If you have thoughts of killing or harming yourself (suicidal tendencies).
• If you are planning or due to have a surgery that requires anaesthetic.
• If you drink alcohol.
• If you have a condition called porphyria.
• If you have a problem with your thyroid gland.
• If you have a liver condition/disorder.
• If you have and eye condition called glaucoma which is an increase in eye pressure.
• If you develop an allergic skin reaction (skin rash, itching, swelling of the face/tongue) after taking AMDERIP.
• If you suffer from fits or seizures (epilepsy).
• If you have problems passing urine (urinary retention).
• If you have an enlarged prostate.
• If you are having electroconvulsive therapy (ECT) which is procedure when electric currents are passed through the brain.
• If you develop low sodium levels in your blood you may feel the following symptoms: drowsiness, confusion or have fits/seizures.
• If you are older 65 years of age.
• If you are younger than 18 years of age as AMDERIP is not recommended.
• AMDERIP should at all times be kept out of reach of children as even small doses may be fatal to them.
• Drowsiness is often experienced at the start of AMDERIP therapy.

Lactose warning

AMDERIP contains lactose which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking AMDERIP.

Do not share medicines prescribed for you with any other person. Always take AMDERIP exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is: Initially 75 mg to 150 mg daily in divided doses. Maintenance dose is 50 mg to 100 mg daily in divided doses. Your doctor will tell you how long your treatment with AMDERIP will last.

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

If you take more AMDERIP than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Take this leaflet and any remaining tablets with you, so that the doctor knows what you have taken. You may experience an increase in side effects caused by AMDERIP such as drowsiness, restlessness, unsteady body movement, unconscious state (coma), stunned state in which it is difficult to get a response or the attention (stupor), changes in your normal heartbeat (cardiac dysrhythmias), fever, irregular heartbeats that you can feel (palpitations), low blood pressure (hypotension), fast heart rate (tachycardia), fits/seizures and difficulty breathing.

If you forget to take use AMDERIP

If you forget to take a tablet, take the missed dose right away, unless it is almost time for your next dose. Do not take a double dose to make up for forgotten individual doses.

If you stop taking using AMDERIP

Do not stop taking AMDERIP or decrease the dose without checking with your doctor.

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

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

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

These are all very serious side effects. If you have them, you may have had a serious reaction to AMDERIP. 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:

• Heart attack: symptoms may include pain or pressure in your chest, discomfort spreading to the back, arm, throat or jaw, heartburn or indigestion, shortness of breath, anxiety, weakness or rapid/irregular heartbeats.
• Stroke: symptoms may include sudden numbness (loss of feeling) or weakness of the face, arm or leg especially on one side of the body, confused state, trouble speaking or understanding speech, sudden trouble seeing in one or both eyes, sudden trouble walking, loss of balance or coordination, dizziness and sudden severe headache without a known cause.
• Yellowing of skin and eyes (jaundice).
• Coma (state of unconsciousness).
• Feeling faint when getting up (postural hypotension), palpitations, fast/racing heart, increased blood pressure, slow or irregular heartbeats, and very low blood pressure.
• Bone marrow depression or a decrease in some blood cells. You may experience bleeding or bruising easily, recurring infections or mouth ulcers.
• Difficulty passing water (urine).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Drowsiness or sleepiness.
• Blurred vision, increased pressure in the eye or difficulty focusing when looking at an object (accommodation disturbances).
• Constipation.
• Dry mouth.

Less frequent side effects:

• Skin rash that looks like pale red itchy bumps (urticaria).
• Reaction of skin to sunlight.
• Inadequate secretion of ADH (antidiuretic hormone) causing you to urinate more often, changes in blood sugar level and blood sodium levels.
• Dizziness, headache, weakness, numbness or pain in hands or feet, pins and needles, lack of coordination, unsteady body movement (ataxia), tremors (shaking), fits, stiff or jerky movements of your face and body that you can't control.
• Enlarged (dilated) pupil of the eyes.
• Confusion, not knowing where you are (disorientation), agitation, feeling anxious, restlessness, difficulty sleeping, nightmares, unable to concentrate.
• Suicidal thoughts or behavior, changes in behavior.
• Difficulty speaking due to muscle weakness.
• Ringing sound in the ears.
• Diarrhoea, constipation, feeling sick (nausea), being sick (vomiting), swelling in the mouth, dry mouth, swelling or the parotid gland which produces saliva or spit, black tongue, stomach pain.
• Swelling of the liver (hepatitis).
• Temporary hair loss.
• Passing water (urine) more often.
• Breast swelling in men and women, flow of milk from breast when not breastfeeding, swelling of testicles, changes in sex drive.
• Feeling tired or weak.
• Increased sweating.

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 AMDERIP.

Store all medicines out of reach of children. Store at or below 25 °C. Store in the original package/container. Do not store in a bathroom. Do not use AMDERIP after the expiry date. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).