Nystimex 100 000 IU/ml, Nystimex oral suspension
nystatin
what Nystimex Is And What It Is Used For
Nystimex 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.
Nystimex is used to treat fungal infections in the mouth and intestines.
Nystatin contained in Nystimex may also be approved for treating other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have further questions, and always follow their instructions.
What You Need To Know Before Using Nystimex
Do Not Use Nystimex
- 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 or pharmacist before using Nystimex.
Other Medicines And Nystimex
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, Breastfeeding, And Fertility
Pregnancy
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.
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 Nystimex passes into breast milk. If 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 can drive a motor vehicle or perform work requiring sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects 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.
Nystimex 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, i.e., it is almost “sodium-free.”
How To Use Nystimex
- 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 adolescents.
- The recommended dose for children and infants 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 adolescents.
- The recommended dose for children and infants 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 Nystimex 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 Nystimex
- Do not take a double dose to make up for a forgotten dose.
- If you have any further questions about the use of this product, ask your doctor or pharmacist.
Possible Nystimex Side Effects
This medicine can cause side effects like all medicines, although not everybody gets them.
Stop using Nystimex 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 rare side effect 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 Nystimex 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.
If any side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How To Store Nystimex
- Keep this medicine out of sight and reach of children.
- Store unopened bottles in a refrigerator (2ºC – 8ºC).
- It can be stored during use for a maximum of 25ºC for a maximum of 1 month.
- Do not use this medicine after the expiry date stated on the bottle after EXP. That. The expiration date is the last day of the specified month.
- Do not use this medicine if you notice visible signs of deterioration in the appearance of the medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are 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:
- Xylitol
- Caramel sodium
- Methyl parahydroxybenzoate (E218)
- Peppermint oil
- Purified water
- The oral suspension is sweetened with xylitol
What The Medicine Looks Like And Contents Of The Pack
- Nystimex oral suspension is yellow and has a mint taste.
- Pack size 100 ml glass bottle.
- In some markets, a 5 ml graduated polyethylene/polystyrene syringe may be provided.
Marketing Authorisation Holder
Manufacturer
Recipharm Parents SLU
C / Ramón y Cajal 2
ES-08150 Parets del Vallès
Spain
Information provided by:
As time Pharma AB
Isafjordsgatan 36
164 40 Kista
Tel. 08-5151 1535
info@astimex.se
This medicinal product is authorized under the European Economic Area under the names:
| Denmark | Nystimex 100,000 IU / ml oral suspension |
| Finland | Nystimex 100,000 IU / ml oral suspension |
| Iceland | Nystimex 100,000 IU / ml oral suspension |
| Netherlands | Nystatin RPH 100,000 IU / ml, suspension for oral use |
| Norway | Nystimex 100,000 IU / ml oral suspension |
| Sweden | Nystimex 100,000 IU / ml oral suspension |