Scheduling Status
ZYACTIN 4 mg tablets are classified as S2 medicine. The active ingredient is cyproheptadine as hydrochloride. Each tablet contains 4 mg cyproheptadine and also contains 40 mg lactose monohydrate per tablet.
Overview
ZYACTIN contains cyproheptadine, which belongs to a group of medicines called sedating antihistamines. It is used to relieve allergic conditions, including hay fever and certain allergic skin conditions.
This medicine should only be used by the person for whom it was prescribed. It should not be shared with other people, even when their symptoms appear similar.
1. What ZYACTIN Is and What It Is Used For
ZYACTIN is an antihistamine medicine used for the relief of allergy symptoms. It may be used in conditions such as hay fever and some allergic skin reactions. Because it is a sedating antihistamine, it may cause drowsiness or reduced alertness in some people.
2. What You Need to Know Before Taking ZYACTIN
Do Not Take or Give ZYACTIN
ZYACTIN should not be taken or given in the following situations:
| Do not use ZYACTIN if | Reason / concern |
|---|---|
| You or your child is allergic to cyproheptadine or any ingredient in the medicine | Risk of allergic reaction |
| You or your child has glaucoma or increased pressure in the eyes | The medicine may worsen the condition |
| You have prostate problems or difficulty passing urine | The medicine may worsen urinary problems |
| You or your child is taking MAOIs | Risk of medicine interaction |
| You or your child has a stomach ulcer or intestinal blockage | The medicine may not be suitable |
| You are elderly or very weak | Higher risk of side effects |
| You are breastfeeding | ZYACTIN should not be used while breastfeeding |
Warnings and Precautions
Special care is needed if ZYACTIN causes dizziness, drowsiness, or low blood pressure. Patients with asthma, underactive thyroid, high blood pressure, heart disease, or respiratory disease should speak to a healthcare provider before using this medicine.
ZYACTIN may affect blood or urine test results. A doctor may advise stopping it for several days before testing. It is also not intended for the treatment of acute asthma attacks. Patients with asthma should follow their doctor’s asthma action plan and keep their rescue inhaler available.
Use in Children
ZYACTIN should not be given to children under 2 years of age, because safety and effectiveness have not been established in this age group.
Other Medicines and ZYACTIN
Patients should tell their doctor, pharmacist, or healthcare provider about all medicines they are taking, including complementary or traditional medicines.
Particular care is needed with:
| Medicine type | Use |
|---|---|
| Hypnotics, sedatives, tranquillisers | Used for sleeping problems or anxiety |
| Antidepressants | Used for depression |
ZYACTIN With Food, Drink and Alcohol
ZYACTIN may be taken with or without food. Alcohol should be avoided because it may increase drowsiness, reduce alertness, and impair performance.
Pregnancy, Breastfeeding and Fertility
Anyone who is pregnant, breastfeeding, thinks they may be pregnant, or plans to have a baby should consult a doctor, pharmacist, or healthcare provider before taking ZYACTIN. The safety of ZYACTIN during pregnancy has not been established, and it should not be taken while breastfeeding.
Driving and Using Machines
ZYACTIN can cause drowsiness and impaired concentration. Patients should not drive, operate machinery, or perform tasks requiring attention after taking ZYACTIN if affected.
Lactose Information
ZYACTIN contains lactose. Patients who have been told by a doctor that they have an intolerance to some sugars should consult their doctor before taking it.
3. How to Take ZYACTIN
ZYACTIN should be taken exactly as described in the approved leaflet or as instructed by a doctor or pharmacist.
Recommended Dosage
| Patient group | Usual dose | Maximum daily dose |
|---|---|---|
| Adults | 12 mg to 16 mg daily; starting dose 4 mg three times daily | 20 mg daily |
| Children 7 to 14 years | 4 mg two or three times daily; extra dose preferably at bedtime if needed | 16 mg daily |
| Children 2 to 6 years | 2 mg two or three times daily; extra dose preferably at bedtime if needed | 8 mg daily |
ZYACTIN may be taken with or without food. Patients who feel the medicine is too strong or too weak should speak to a doctor or pharmacist.
If Too Much ZYACTIN Is Taken
In the event of overdose, contact a doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. The remaining medicine and leaflet should be taken along so healthcare professionals know what was taken.
If a Dose Is Missed
A double dose should not be taken or given to make up for a forgotten dose.
4. Possible Side Effects
ZYACTIN can cause side effects. Not all possible side effects are included in the leaflet. If health worsens or unexpected effects occur, a healthcare provider should be consulted.
Side Effects Table
| Side-effect category | Side effects / symptoms | Action required |
|---|---|---|
| Very serious allergic reactions | Swelling of hands, feet, ankles, face, lips, mouth, or throat; difficulty swallowing or breathing; rash; itching; fainting | Stop taking or giving ZYACTIN and seek urgent medical help immediately |
| Serious side effects | Frequent infections, fever, severe chills, sore throat, mouth ulcers, unusual bleeding or bruising, seizures, changes in heartbeat, anaphylactic shock, yellowing of skin or eyes, dark urine, tiredness linked to liver problems, painful or difficult urination, incomplete bladder emptying, urinary frequency | Contact a doctor immediately or go to the nearest casualty department |
| Frequent side effects | Sleepiness or drowsiness | Tell a doctor if troublesome or persistent |
| Less frequent side effects | Sedation, restlessness, confusion, excitement, exaggerated emotions, nervousness, irritability, aggressive behaviour, anaemia symptoms, increased appetite, weight gain, headache, dizziness, coordination problems, tremors, pins and needles, sleep problems, unrealistic feeling of well-being, hallucinations, vertigo, blurred or double vision, tinnitus, low blood pressure, respiratory symptoms, blocked nose, nosebleeds, dry mouth/nose/throat, abdominal discomfort, nausea, vomiting, diarrhoea, constipation, loss of appetite, abnormal liver function, sun sensitivity, urticaria, sweating, early menstrual period, tiredness, chills with raised temperature | Tell a doctor |
| Frequency unknown side effects | Reduced mental alertness, confusion, hallucinations, restlessness, excitation, aggressive behaviour, euphoria | Tell a doctor or pharmacist |
| Side effects not listed | Any unexpected side effect | Inform a doctor or pharmacist |
Reporting Side Effects
Side effects may be reported to SAHPRA using the adverse drug reaction reporting process. Reporting helps provide more information on the safety of the medicine.
5. How to Store ZYACTIN
ZYACTIN should be stored at or below 25 °C. The blister strips should be kept in the outer carton until needed. Medicines should be kept out of the reach of children and should not be used after the expiry date printed on the blister strip or carton. Unused medicine should be returned to a pharmacist and should not be disposed of in drains, toilets, or sewerage systems.
6. Contents of the Pack and Other Information
What ZYACTIN Contains
Each tablet contains 4 mg cyproheptadine as hydrochloride. The other ingredients include lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.
What ZYACTIN Looks Like
ZYACTIN tablets are white to off-white, round, flat-faced tablets with a bevelled edge. They are bisected on one side and debossed on the other side. The pack contains aluminium/aluminium blister strips of 10 tablets, packed in an outer carton containing 30 tablets.
Holder of Certificate of Registration
The holder of certificate of registration is Zydus Healthcare SA (Pty) Ltd, Southdowns Office Park, Building B, Ground Floor, 22 Karee Street, Centurion, Pretoria, 0157.
Registration Details
| Item | Detail |
|---|---|
| Registration number | 55/5.7.1/0847 |
| Date of registration | 06 February 2024 |
| Leaflet last revised | Not applicable |
Disclaimer
This article is an information-format version based on the approved patient information leaflet. It should not replace medical advice from a doctor, pharmacist, or healthcare provider. For SAHPRA-compliant publication, the approved patient information wording should be used exactly as authorised.
