TumsUP Drops
Therapy Area
Gastrointestinal
1.0 Generic name
Simethicone, Dill Oil and Fennel Oil Liquid
2.0 Qualitative and quantitative composition
Each ml contains :
Simethicone Emulsion
equivalent to Simethicone USP 40 mg
Dill Oil BP 0.005 ml
Fennel Oil 0.0007 ml
In Syrupy Base
3.0 Dosage form and strength
Oral drops
4.0 Clinical particulars
4.1 Therapeutic indication
Treatment of infantile colic
4.2 Posology and method of administration
For paediatric use only formulation.
Infants (below 6 months) : 5-10 drops 4 times daily, 15 minutes before feed.
Infants (6-12 months) : 10-20 drops 4 times daily, 15 minutes before feed.
Children (over 1 year) : 20 drops 4 times daily, 15 minutes before feed or as directed by the Physician.
4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients.
4.4 Special warnings and precautions for use
- Shake well before use.
- Cap should be tightly closed immediately after every use.
- Use calibrated dropper provided in this pack.
4.5 Drugs interactions
Levothyroxine may bind to Simethicone. Absorption of Levothyroxine may be impaired if the preparation is given concurrently to infants treated for thyroid disorders.
4.6 Use in special populations
For paediatric use only.
4.7 Effects on ability to drive and use machines
Not applicable
4.8 Undesirable effects
Simethicone does not have any serious side effects.
Minor adverse effects : Nausea, Mild diarrhea and Constipation. Rarely, hypersensitivity reactions such as rash, pruritis, facial oedema, tongue oedema and respiratory difficulty have been reported.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via email to : medico@zuventus.com
Website : http ://www.zuventus.co.in/safety.aspx
By reporting side effects, you can help provide more information on the safety of this medicine.
4.9 Overdose
In the event of deliberate or accidental overdose, treat symptoms on appearance.
5.0 Pharmacological properties
5.1 Mechanism of action
Excessive swallowing of air results in collection of gas in the intestine. This can be the result of too rapid eating, breast feeding babies where they inhale air along with the milk, excessive use of a pacifier (dummy), finger sucking or yelling. Simethicone, Dill Oil and Fennel Oil Liquid Relieves Infant Colic, Griping Pain & Flatulence When the swallowed air is in the intestine, bubbles are formed, which makes it more difficult for the gas to pass through the intestine canal, resulting in abdominal distension and pain.
Simethicone
Simethicone is used to relieve painful pressure caused by excess gas in the stomach and intestines. Simethicone is a surface active substance which changes the surface tension of the intestinal mucus allows gas bubbles in the stomach and intestines to come together. Thus, the air bubbles burst and the gas is released for easier passage of gas. The elimination of the gas, air or foam from the gastro-intestinal tract, relieves abdominal distension and dyspepsia.
Dill oil and fennel oil
Contains volatile oils that produce smooth muscle relaxation, an antispasmodic effect and increases intestinal motility. Dill and Fennel Oils are also used for digestion problems including intestinal gas (flatulence) and constipation.
5.2 Pharmacodynamic properties
Simethicone reduces surface tension and collapses gas bubbles, thus act as an 'antifoaming agent' and relieve flatulence. Dill Oil and Fennel Oil produce an antispasmodic effect and increases intestinal motility.
5.3 Pharmacokinetic properties
Physiologically the active ingredient Simethicone is a chemically inert. Simethicone is not absorbed from the gastrointestinal tract and is excreted unchanged in the faeces.
6.0 Nonclinical properties
6.1 Animal toxicology or pharmacology
No known animal toxicology data
7.0 Description
TumsUp drops is a fixed dose combination of Simethicone (40 mg) + Dill Oil (0.005 ml) + Fennel Oil (0.0007 ml) per ml. Simethicone is inert oil, which is tissue adherent and water repellent, it is therefore mucosal protective. Dill and Fennel Oils are essential oils extracted from the seeds or leaves/stems of Anethum Graveolens (Dill plant) and Foeniculum Vulgare respectively. Dill (Anethum Graveolens) has seeds containing volatile oils rich in carvone. Fennel (Foeniculum Vulgare) seeds hold another Volatile Oil, Anethole.
8.0 Pharmaceutical particulars
8.1 Incompatibilities
Not applicable
8.2 Shelf-life
24 Months
8.3 Packaging information
A glass bottle of 30 ml.
8.4 Storage and handing instructions
Store below 25°C. Protect from light. Do not Freeze. KEEP AWAY FROM THE REACH OF CHILDREN.
9.0 Patient counselling information
- Ask the patient to report any adverse events.
- Not to exceed the stated recommended daily dose.
12.0 Date of issue
05 February 2022
Read all of this leaflet carefully before your child starts taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What TumsUP Drops are and what are they used for
2. What you need to know before you take TumsUP Drops
3. How to take TumsUP Drops
4. Possible side effects
5. How to store TumsUP Drops
6. Contents of the pack and other information
1. What TumsUP Drops is and what it is used for
TumsUP Drops contains Simethicone, Dill Oil and Fennel Oil Liquid.
Simethicone belongs to a group of medicines called surface active substances. It works by helping to release trapped wind. This helps to relieve tummy pain and indigestion. Dill oil and fennel oil contains volatile oils that produce smooth muscle relaxation, an antispasmodic effect and increases intestinal motility. Dill and fennel oils are also used for digestion problems including intestinal gas and constipation.
TumsUP Drops are for the gentle relief of wind and griping pains and flatulence in babies.
This medicine can be used from birth onwards.
2. What you need to know before you use TumsUP Drops
Do not give TumsUP Drops if your baby is being treated for a thyroid disorder, seek advice from your doctor instead.
Do not give TumsUP Drops if you think your baby might be allergic (hypersensitive) to Simethicone, Dill Oil and Fennel Oil Liquid.
Taking other medicines
If your baby is being treated with levothyroxine for a thyroid disorder, using TumsUP Drops might reduce the amount of this type of medicine that is absorbed, weakening the effect of their treatment.
3. How to take TumsUP Drops
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
For paediatric use only formulation.
SHAKE WELL BEFORE USE.
Use calibrated dropper provided in this pack.
In infants (below 6 months) 5-10 drops should be given 4 times daily, 15 minutes before feed.
In Infants (6-12 months) 10-20 drops should be given 4 times daily, 15 minutes before feed. 4
Children (over 1 year) should be given 20 drops 4 times daily, 15 minutes before feed or as directed by the Physician.
Replace cap tightly immediately after each use.
If you use more TumsUP Drops than you should, contact your health advisor for advice.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any signs of allergy, stop using the product and seek medical advice.
Minor adverse effects: nausea, mild diarrhoea and constipation. Rarely, hypersensitivity reactions such as rash, itching, facial swelling, tongue oedema and respiratory difficulty have been reported.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly: Website: www.zuventus.co.in and click the tab “Safety Reporting” located on the top right end of the home page.
By reporting side effects, you can help provide more information on the safety of this medicine.
You can also report the side effect with the help of your treating physician.
5. How to store TumsUP Drops
Keep this medicine out of the sight and reach of children.
Store in a cool place. Away from light.
Do not take Tumps UP Drops after the expiry date which is stated on the carton. The expiry date refers to the last day of that month after EXP.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist on how to dispose of medicines no longer required. These measures will help protect the environment.
6. Contents of the pack and other information
What TumsUP Drops contains
Each ml contains:
Simethicone Emulsion equivalent to Simethicone USP 40 mg
Dill Oil BP 0.005 ml
Fennel Oil 0.0007 ml
In syrupy base
Packaging
A bottle of 30 ml
