100,000 IU / ml oral suspension
nystatin
What Nystatin Orifarm is and what it is used for
Nystatin Orifarm belongs to the group of medicines for fungal infections. The active substance is nystatin. It acts locally in the mucous membrane and is not absorbed into the body.
Nystatin Orifarm is used to treat fungal infections of the mouth and intestines.
Nystatin contained in Nystatin Orifarm may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you use Nystatin Orifarm
Do not use Nystatin Orifarm
- if you are allergic to nystatin or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Nystatin Orifarm.
Other medicines and Nystatin Orifarm
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
You should only use this medicine if your doctor thinks the benefit outweighs the potential risk to the fetus.
Breast-feeding
It is not known if Nystatin Orifarm passes into breast milk. If you are breastfeeding, ask your doctor for advice before using this medicine.
Driving and using machines
There is no known effect on the ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Nystatin Orifarm contains methyl parahydroxybenzoate and sodium
Methyl parahydroxybenzoate may cause allergic reactions (possibly delayed).
This medicine contains 1.2 mg sodium per ml oral suspension, which is less than 23 mg per dose, ie it is almost “sodium-free”.
How to use Nystatin Orifarm
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The doctor or dentist will determine the dose and adjust it individually for you.
The bottle is shaken well before use.
Fungal infection of the oral cavity: The recommended dose for adults is 1 ml, 4 times daily. Suspension is preferably taken after meals and kept in the mouth as long as possible before swallowing.
Use for children and infants:
The recommended dose for children (over 2 years), infants (from 1 month to 2 years), and newborns (from birth to 1 month) is 1 ml, 4 times daily. Suspension is preferably taken after meals and kept in the mouth as long as possible before swallowing. For infants, a suspension may be given dropwise or diluted with a little water and brushed in the mouth.
Fungal infection of the intestine: The recommended dose for adults is 5 ml 3 times daily. Suspension one is swallowed immediately. For infection not to return, treatment should be continued 2-3 days after all signs of infection have disappeared.
Use for children and infants:
The recommended dose for children (over 2 years) and infants (from 1 month to 2 years) is 1 ml, 4 times daily. Suspension one is swallowed immediately. For infection not to return, treatment should be continued 2-3 days after all signs of infection have disappeared.
If you use more Nystatin Orifarm than you should
If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you forget to use Nystatin Orifarm
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Nystatin Orifarm immediately and tell your doctor if you get any of the following symptoms:
- Severe skin and mucous membrane changes (so-called Stevens Johnson syndrome).
This is a rare side effect that may affect up to 1 in 1,000 people. - Hypersensitivity reaction and localized skin swelling ( angioedema ), a reaction in which the face and neck can swell sharply.
Hypersensitivity reactions caused by this medicine are very rare (may affect up to 1 in 10,000 people) or have no known frequency (can not be calculated from the available data).
Uncommon side effects ( may affect up to 1 in 100 people):
- Allergic skin reactions
High doses can cause stomach problems such as nausea, vomiting, and diarrhea.
How to store Nystatin Orifarm
Unopened bottle: no special storage instructions.
Opened bottle: Store at a maximum of 25 ° C for a maximum of 2 months.
Do not use this medicine after the expiry date which is stated on the bottle after EXP. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is nystatin. 1 ml of suspension contains 100,000 international units (IU) of nystatin.
- Other ingredients are:xylitolcaramel sodiummethyl parahydroxybenzoate (E218)peppermint oilpurified watersodium hydroxide (for pH adjustment)hydrochloric acid (for pH adjustment)
The oral suspension is sweetened with xylitol.
What the medicine looks like and contents of the pack
Nystatin Orifarm oral suspension is yellow and has a mint taste.
Pack size 100 ml amber glass bottle
Marketing Authorization Holder and Manufacturer
Orifarm Generics A / S
Energizer 15
5260 Odense S
Denmark
Local representative
Orifarm Generics AB
Box 56048
102 17 Stockholm