Schedule 4 (S4)
This means ALTOSEC 20 is a prescription-only medicine in South Africa.
What is it?
ALTOSEC 20 mg contains omeprazole, a medicine that belongs to a class known as proton pump inhibitors (PPIs). These medicines work by reducing the amount of acid your stomach produces.
It is commonly used to treat acid-related disorders of the stomach and intestines.
Composition per Capsule
| Ingredient | Strength |
|---|---|
| Omeprazole | 20 mg |
| Lactose anhydrous | 8 mg |
| Mannitol | 142 mg |
What is it Used For?
ALTOSEC 20 is prescribed for the treatment of various acid-related conditions, such as:
- Heartburn and acid reflux (Gastro-oesophageal reflux disease or GORD), which is caused when stomach acid escapes into the oesophagus.
- Duodenal ulcers (ulcers in the upper part of the small intestine) and gastric ulcers (stomach ulcers).
- Inflammation of the food pipe due to acid reflux.
- Ulcers caused by Helicobacter pylori infection, in combination with antibiotics.
- Zollinger-Ellison syndrome, a rare condition that causes the stomach to produce too much acid.
- NSAID-associated ulcers, either for treatment or to prevent ulcers in people who need to stay on NSAIDs long-term.
Before You Take ALTOSEC 20
Do Not Take ALTOSEC 20 If:
- You are allergic to omeprazole, any similar drugs, or any ingredient in the capsule.
- You are pregnant or breastfeeding.
- You are taking atazanavir or nelfinavir for HIV.
Warnings and Precautions
Talk to your doctor before using ALTOSEC 20 if:
- You experience blistering, skin peeling, or severe rashes. These may be signs of serious skin reactions like Stevens-Johnson Syndrome, TEN, or DRESS.
- You have symptoms such as unexplained weight loss, difficulty swallowing, vomiting blood, bloody or black stools, or persistent stomach pain.
- You experience diarrhoea with abdominal pain and fever, which could be due to infections.
- You are undergoing a Chromogranin A blood test or any tests for hormone or nervous system tumors.
- You have osteoporosis or are taking corticosteroids, as PPIs can increase the risk of bone fractures.
- You suffer from severe liver problems. Your doctor may reduce your dose.
- You are using ALTOSEC 20 long-term, as it may lead to:
- Low magnesium, potassium, or calcium levels
- Stomach glandular cysts (usually non-cancerous)
- Kidney inflammation (tubulointerstitial nephritis)
- Vitamin B12 deficiency, especially in people with risk factors
- Skin lesions in sun-exposed areas, which may suggest subacute cutaneous lupus erythematosus (SCLE)
Children and Adolescents
There is currently no data on the safety or use of ALTOSEC 20 in children or adolescents.
Interactions with Other Medicines
Always inform your healthcare provider about any other medicines or supplements you are taking, including traditional or herbal remedies.
| Medicine Type | Examples |
|---|---|
| Antifungals | Ketoconazole, Itraconazole, Voriconazole |
| HIV Medications | Saquinavir, Atazanavir, Nelfinavir |
| Heart Medicines | Digoxin, Warfarin |
| Epilepsy Meds | Diazepam, Phenytoin |
| Immunosuppressants | Tacrolimus, Methotrexate |
| Herbal Remedies | St John’s Wort |
| Antiplatelets | Clopidogrel, Cilostazol |
| TB Medication | Rifampicin |
If any of these apply to you, your doctor may monitor you closely or adjust your treatment.
Taking ALTOSEC 20 with Food and Alcohol
Food and alcohol do not affect the absorption of ALTOSEC 20, so you can take it with or without meals. However, it is typically recommended to take it before food in the morning for best results.
Pregnancy and Breastfeeding
ALTOSEC 20 should not be used during pregnancy or breastfeeding. If you think you are pregnant or are planning to become pregnant, speak with your doctor before starting the medication.
Driving and Operating Machinery
ALTOSEC 20 may cause drowsiness or dizziness in some people. Wait to see how it affects you before driving or using heavy machinery.
Sugar Content
ALTOSEC 20 contains:
- Lactose – if you have lactose intolerance, speak to your doctor before taking this medicine.
- Mannitol – may have a laxative effect in some individuals.
How to Take ALTOSEC 20
Always take ALTOSEC 20 exactly as prescribed by your doctor. Do not stop or change the dosage without medical advice.
General Guidelines
- Take the capsule once daily, preferably in the morning before food, with half a glass of water.
- Swallow the capsule whole. Do not chew or crush it.
For People Who Cannot Swallow Capsules
You may:
- Open the capsule and mix its contents with a small amount of slightly acidic liquid (like fruit juice or applesauce), or
- Swallow the pellets with half a glass of water without chewing.
- Consume the mixture immediately (within 30 minutes).
Usual Doses Based on Condition
| Condition | Dosage & Duration |
|---|
| Duodenal Ulcer | 20 mg once daily for 2–4 weeks |
| Gastric Ulcer or Acid Reflux | 20 mg once daily for 4–8 weeks (may increase to 40 mg) |
| H. pylori Ulcers | With antibiotics, as prescribed |
| Zollinger-Ellison Syndrome | Starting dose of 60 mg/day; adjusted as needed |
| NSAID Ulcers | 20 mg daily for healing and prevention |
Do not share this medicine with anyone else, even if they have the same symptoms.
What If You Take Too Much?
If you accidentally take more than the prescribed dose, contact your doctor, pharmacist, or a hospital immediately, especially if you feel unwell.
Possible Side Effects
Like all medicines, ALTOSEC 20 can cause side effects, although not everyone gets them.
Common Side Effects
- Headache
- Stomach pain or discomfort
- Nausea or vomiting
- Diarrhoea
- Constipation
- Gas (flatulence)
Uncommon Side Effects
- Sleep disturbances
- Dizziness
- Skin rash or itching
- Fatigue
- Increased liver enzymes (detected in blood tests)
Rare or Serious Side Effects
Seek medical help immediately if you experience:
- Severe allergic reactions: swelling of the face, lips, throat; difficulty breathing
- Severe skin rashes or blistering (Stevens-Johnson syndrome, TEN)
- Yellowing of the skin or eyes (jaundice)
- Changes in mood or confusion
- Muscle weakness or cramps (possibly due to low magnesium levels)
- Unusual bleeding or bruising
- Kidney problems: blood in urine, swelling, or fatigue
Long-term Side Effects
If used for a long time, ALTOSEC 20 may lead to:
- Low magnesium, calcium, or potassium levels
- Vitamin B12 deficiency
- Fractures (hip, wrist, spine)
- Stomach cysts (non-cancerous)
- Kidney inflammation
- Skin conditions like lupus (SCLE)
Your doctor may recommend regular blood tests to monitor your health if you’re using ALTOSEC 20 long-term.
How to Store ALTOSEC 20
- Store the capsules in the original packaging.
- Keep them out of sight and reach of children.
- Do not use the medicine after the expiry date on the package.
- Store at room temperature, away from moisture and heat.
Packaging and Appearance
ALTOSEC 20 is available in capsule form and is typically supplied in a blister pack. Always check the packaging for exact details and the expiry date.
Final Notes
ALTOSEC 20 is a powerful and effective medication for managing various stomach acid-related conditions. However, it must be used responsibly and only under medical supervision. Make sure to attend regular check-ups if you’re on long-term therapy, and always report any unusual symptoms or side effects to your healthcare provider.
If you have further questions or concerns, don’t hesitate to consult your doctor, pharmacist, or nurse.
Sources:
Here’s a list of sources for the information about ALTOSEC 20 mg Capsules (omeprazole):
- Acino EduDoc – Altosec 20 mg Product Information
https://acinoedudoc.com/wp-content/uploads/2024/11/Altosec-20.pdf - Mayo Clinic – Omeprazole (Oral Route)
https://www.mayoclinic.org/drugs-supplements/omeprazole-oral-route/description/drg-20066836 - Medical News Today – Omeprazole Oral Capsule
https://www.medicalnewstoday.com/articles/omeprazole-oral-capsule
