INDICATION:
- Treatment of symptoms of vomiting and nausea.
- Treatment of nausea, vomiting, sensation and severe epigastric, indigestion after meals due to slow food down to the intestine.
USER TARGET:
- People who have digestive problems, anorexia, flatulence, indigestion, vomiting
DOSAGE AND ADMINISTRATION:
- Adults and adolescents (aged 12 years or older and weighing 35 kg or more): 1-2 sachets, up to 3 times a day, with a maximum dose of 6 packs per day.
- Children from 1 to under 12 years old and minors weighing less than 35 kg: Dosage is 0.25 mg/kg. May be used 3 times a day with a maximum dose of 0.75mg/kg per day.
- For example, for a child weighing 10 kg, the dose is 2.5 mg, which can be taken 3 times a day with a maximum dose of 7.5 mg/kg.
CONTRAINDICATIONS:
- Hypersensitivity to domperidone, simethicone or to any of the ingredients.
WARNING AND IMPORTANT WHEN USING DRUGS:
- Ask doctor before using this medicine:
- If you have liver disease or are careful, include alcoholic liver disease.
- Dome Plus HS is not toxic at therapeutic doses, and when used under the guidance of a physician. However, overdose of domperidone can cause liver failure. Taking multiple products containing domperidone at the same time can lead to harmful consequences (such as domperidone overdose).
- Do not exceed the prescribed dose.
- You should avoid drinking too much caffeine (e.g., coffee, tea, and some cans) when using this product.
USING DRUGS FOR PREGNANT AND LACTATING WOMEN:
Pregnant:
- Notify the doctor for treatment or pharmacist if the patient is pregnant and lactating. Because the drug can be secreted through breast milk, the domperidone can cause harmful effects on the baby’s heart.
- Therefore, only use Motilium (domperidone) for pregnant and lactating women with the consent of a doctor.
Breastfeeding period:
- Lactation: Domperidone is excreted in human milk and the nursing infant received less than 0.1% of the maternal weight-based dose. Adverse effects, especially cardiovascular effects, can still occur after the infant is breastfed. The benefits of breastfeeding and the benefits of treatment for the mother should be weighed before deciding whether to discontinue nursing or to discontinue/avoid treatment with domperidone. Caution should be exercised in the event that there are risk factors for prolongation of the QT interval in the breastfed infant.
UNDESIRABLE EFFECTS:
- For domperidone:
Undesirable effects associated with domperidone include dry mouth, abdominal cramps, diarrhea, nausea, rash, itching, hives, and hyperprolactinemia (the symptoms of which may include breast enlargement, galactorrhea, breast pain/tenderness, gynecomastia, hypogonadism, and menstrual irregularities). - For Simethicone:
Simethicone is obviously not toxic and there is no report on side effects. Simethicone is recommended not to be used to treat abdominal pain in infants because there is very little information about the safety of the drug for babies and children. Simethicone is not absorbed through the gastrointestinal tract, so it does not have dynamic and biological activity. It does not cause harmful effects. Due to the non-absorbing nature, clinical reports are not found to have any clinical or toxic side effects. In addition, Simethicone is commonly prescribed in combination with antacids.
OVERDOSE AND TREATMENT:
- For domperidone
- Symptom: Symptoms of overdose may include agitation, altered consciousness, convulsions, disorientation, somnolence, and extrapyramidal reactions.
- To solve: There is no specific antidote to domperidone, but in the event of overdose, standard symptomatic treatment should be given immediately. Gastric lavage as well as the administration of activated charcoal may be useful. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation. Close medical supervision and supportive therapy is recommended.
- For Simethicone
- Symptom: Serious symptoms of using Simethicone can be mentioned as fainting, shortness of breath.
- To solve: Do not use more than the prescribed dose. Taking more medication will not improve your symptoms; rather, they may cause poisoning or serious side effects. If you suspect that you or anyone else who may have overdosed on Simethicone M30, please go to the emergency department of the closest hospital or nursing home. Bring a medicine box, container, or label with you to help doctors with necessary information. Do not give your medicines to other people even if you know that they have the same condition or it seems that they may have similar conditions. This may lead to overdosage. Please consult your physician or pharmacist or product package for more information.
PHARMACOLOGICAL PROPERTIES:
- Pharmacodynamics:
- Domperidone: Domperidone is a dopamine antagonist that stimulates gastrointestinal motility and anti-vomiting. Domperidone has the same sympathetic and receptor-contraceptive resistance with the effect on the receptor activation area. In addition, Domperidone also has a serotonin receptor antagonistic effect (5-HT3) and is used as an anti-vomiting drug in short-term treatment of nausea, vomiting due to different origins.
- Simethicone: Simethicone is a mixture of polydimethylsiloxane and silicon dioxide, and has an anti-foaming effect. Simethicone reduces surface tension of gas bubbles, breaks or gathers them and they will be expelled, resulting in anti-bloating effects. Therefore, simethicone is effective in relieving the symptoms of excessive gastrointestinal gas in both adults and children, which is created from excessive swallowing air or breakdown of certain undigested foods by the bacteria that are present in the colon. Simethicone has been shown to have activity against Helicobacter pylori. The minimal inhibitory concentration (MIC) for simethicone against H. pylori ranges from 64 to 128 mg/L, which can be achieved in the stomach with therapeutic doses. There are some preparations of simethicone combined with antacids, antispasmodics or digestive enzymes; however, the use of these fixed-combination preparations is often unreasonable, and they have not been fully evaluated. However, in some countries, simethicone is also used in combination with antacids to reduce bloating and may reduce hiccup symptoms.
- Pharmacokinetics:
- Domperidone: While absorbed through the intestinal wall, as well as when the liver and blood, aspirin is hydrolyzed into salicylic acid, with the same pharmacological effect as aspirin. With a dose of 500 mg Aspirin, half a lifetime of plasma is 20-30 minutes with aspirin, and 2.5-3 hours with salicylic acid. When the dose is higher, half-life salicylic acid is longer. Aspirin only excreted the kidneys in the form of free or combined salicylate.
- Simethicone: Simethicone is physiologically inert. After oral administration, the drug is not absorbed from the gastrointestinal tract; it does not interfere with gastric acid secretion or absorption of nutrients. Simethicone is excreted unchanged in feces.
STORAGE:
- Store in a cool, dry place, below 30°C, avoid direct sunlight, handle with care.
PACKING:
- Box of 30 sachets of 1.5g
SHELF-LIFE:
- 36 months since manufacture date.
Manufacturer:
- HA TINH PHARMACEUTICAL JSC
No.167 Ha Huy Tap Street, Nam Ha Ward, Ha Tinh City, Ha Tinh Province, Vietnam.
