150 mg capsules, hard
fluconazole
What Solona is and what it is used for
Solona belongs to a group of medicines used against fungal infections. The active substance is fluconazole.
Solona 150 mg when used only as a single dose
Solona is used to treat infections caused by fungi. The most common cause of fungal infections is a yeast called Candida.
You may receive this medicine to treat fungal infection of the vagina or penis (genital fungal infection)
Solona, 150 mg
Solona is used to treat infections caused by fungi, and can also be used to prevent getting a fungal infection. The most common cause of fungal infections is a yeast called Candida.
Adults
You can get this medicine from your doctor to treat the following fungal infections:
- Meningitis is caused by cryptococci – a fungal infection of the brain
- Coccidioidomycosis er – a lung disease
- Infection caused by Candida and found in the bloodstream, internal organs (e.g. heart, lungs), or urinary tract.
- Fungal infection in the mouth that affects the mucous membrane in the mouth, and throat and can cause inflammation in the oral mucosa when using dentures
- Fungal infection in the vagina or on the penis (genital fungal infection)
- Skin infections – e.g. athlete’s foot, ringworm, groin fungus, nail infection
You can also get Solona to prevent:
- that meningitis caused by cryptococci recurs.
- that the fungal infection in the mouth returns.
- recurrent vaginal yeast infection
- infection caused by Candida (if you have a weakened immune system)
Children and young people (0 to 17 years)
You can get this medicine from your doctor to treat these types of fungal infections:
- Fungal infection of the mouth – an infection that affects the mucous membrane of the mouth and throat
- Infections caused by Candida are in the bloodstream, internal organs (eg heart, lungs), or urinary tract.
- Meningitis is caused by cryptococci – a fungal infection of the brain
You can also get Solona to prevent:
- infection caused by Candida (if you have a weakened immune system)
- that meningitis caused by cryptococci recurs
The fluconazole found in Solona may also be approved to treat other conditions not listed in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Solona
Do not use Solona if you:
- are allergic to fluconazole, to other medicines you have taken to treat fungal infection, or to any of the other ingredients of this medicine (listed in section 6). The symptoms can be itching, skin redness, or difficulty breathing.
- taking astemizole or terfenadine (an antihistamine to treat allergies )
- taking cisapride (for upset stomach)
- taking pimozide (used to treat mental disorders)
- taking quinidine (used to treat irregular heart rhythms)
- taking erythromycin ( antibiotic to treat infection ).
Warnings and precautions
Talk to your doctor or pharmacist before using Solona:
- if you have liver or kidney problems
- if you have any heart disease, e.g. irregular heartbeat
- if you have abnormal levels of potassium, calcium, or magnesium in your blood
- if you develop serious skin reactions ( itching, reddening of the skin, or difficulty breathing).
- if you have ever had a severe skin rash or peeling skin, blisters, and/or sores in your mouth after using Solona.
- develop symptoms that may be signs of lower cortisol production from the adrenal glands ( chronic or prolonged fatigue, muscle weakness, decreased appetite, weight loss, abdominal pain.
- if the yeast infection does not get better as you may need to be given another medicine for yeast infection.
Serious skin reactions, including drug reactions with eosinophilia and systemic symptoms (DRESS), have been reported in association with treatment with Solona. Stop using Solona and go to an emergency department immediately if you get any of the symptoms of serious skin reactions described in section 4.
Solona 150 mg when used only as a single dose
Although this medicine is intended for adults, it can be used in adolescents (from 12 to 17 years) if the treatment is necessary and no other options are available. Dosage one should be the same as the adult dosage.
Other medicines and Solona
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tell your doctor immediately if you are taking astemizole, terfenadine (an antihistamine to treat allergies ) or cisapride (used to treat stomach upsets) or pimozide (used to treat mental disorders) or quinidine, amiodarone (used to treat irregular heart rhythm) or erythromycin (antibiotics for the treatment of infection ) as these should not be taken together with Solona (see section “Do not use Solona if you”).
Some medicines can be affected by or affect Solona.
Tell your doctor if you are taking any of the following medicines:
- rifampicin, rifabutin ( antibiotics against infection )
- alfentanil, fentanyl (used as anesthetic)
- amitriptyline, nortriptyline (used to treat depression)
- amphotericin B, voriconazole (for fungal infection)
- blood-thinning medicines (eg warfarin ) to prevent blood clots
- benzodiazepines (eg midazolam, triazolam) used for insomnia or anxiety
- carbamazepine, phenytoin (for epilepsy )
- nifedipine, isradipine, amlodipine, verapamil, felodipine or losartan (for high blood pressure )
- olaparib (used to treat ovarian cancer)
- ciclosporin, everolimus, sirolimus or tacrolimus (used after transplants)
- cyclophosphamide, vinca alkaloids (eg vincristine, vinblastine) used to treat cancer
- halofantrine (for malaria )
- statins (atorvastatin, simvastatin, and fluvastatin) used to lower cholesterol levels in the blood
- methadone (for pain)
- celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (non-steroidal anti-inflammatory drugs, NSAIDs )
- birth control pills
- prednisone ( steroid )
- zidovudine (also called AZT) or saquinavir (used to treat HIV )
- medicines for diabetes such as chlorpropamide, glibenclamide, glipizide or tolbutamide
- theophylline (for asthma )
- tofacitinib (for rheumatoid arthritis )
- tolvaptan (for hyponatremia (low level of sodium in the blood) or to slow the deterioration of kidney function)
- Vitamin A ( nutritional supplement)
- ivacaftor (used to treat cystic fibrosis )
- amiodarone (used to treat irregular heart rhythms ( arrhythmias ))
- hydrochlorothiazide ( diuretics )
- ibrutinib (used to treat blood cancer).
Taking Solona with food and drink
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 using this medicine.
You should not take Solona if you are pregnant, think you may be pregnant or are planning to have a baby, or are breastfeeding unless your doctor has told you to.
If fluconazole is taken during the first trimester of pregnancy, the risk of miscarriage may increase. If fluconazole is taken in low doses during the first trimester, the risk of a child being born with malformations affecting bones and/or muscles may be slightly increased.
You can continue breastfeeding after taking a single dose of Solona up to 150 mg. You should not breastfeed if you take repeated doses of Solona.
Driving ability and use of machinery
When driving and using machinery, you should bear in mind that you may suffer from dizziness or convulsions during the treatment.
You are always responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Solona contains lactose
If you have an intolerance to some sugars, you should consult your doctor before taking this medicine.
How to use Solona
Use for children and adolescents
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Solona 150 mg when used only as a single dose
Swallow the capsule whole with a glass of water.
The medicine can be taken regardless of a meal.
Adults
150 mg as a single dose.
The doctor may prescribe other doses to you than those listed here. Always use Solona as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Older
The usual dose of one for adults can be used.
Patients with kidney problems
The usual dose of one for adults can be used.
How quickly does the treatment start to work?
Vaginal yeast infection
Your discomfort should begin to subside within a couple of days, some women may experience improvement after a day. If the symptoms have not stopped within a couple of days, you should see a doctor again.
Fungal infection in the penis
Your discomfort should begin to subside within a couple of days, but it can last up to a week. If the symptoms have not stopped after a week, you should see a doctor again.
If you have taken too much Solona
You may feel sick if you take too many capsules at once. If you have ingested too much or if e.g. a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poisons Information Center (tel. 112) for an assessment of the risk and advice. The symptoms of a possible overdose may be that you start to hear, see, feel and think things that are not real (hallucinations and paranoid behavior). Treatment of the symptoms and gastric lavage may be necessary in case of overdose.
If you have further questions about this medicine, contact your doctor or pharmacist.
Solona 150 mg
Swallow the capsule whole with a glass of water. You should take the capsules at the same time each day.
The medicine can be taken regardless of a meal.
The table below shows the recommended doses for different infections:
Adults
| Infection | Dose |
| To treat meningitis caused by cryptococci | 400 mg on the first day, then 200 mg to 400 mg once daily for 6 to 8 weeks or longer as needed. Sometimes the dose is increased up to 800 mg |
| To prevent meningitis caused by cryptococci | 200 mg once daily until the doctor says you can stop |
| To treat coccidioidomycosis | 200 mg to 400 mg once daily from 11 months up to 24 months or longer as needed. Sometimes the dose is increased up to 800 mg |
| To treat internal fungal infections caused by Candida | 800 mg the first day, then 400 mg once daily until the doctor says you can stop |
| Fungal infection in the mouth that affects the mucous membrane in the mouth, and throat and can cause inflammation in the oral mucosa when using dentures | 200 mg to 400 mg the first day, then 100 mg to 200 once daily until your doctor says you can stop |
| To treat fungal infection in the mouth – the dose depends on where the infection is | 50 mg to 400 mg once daily for 7 to 30 days until your doctor says you can stop |
| To prevent recurrent fungal infections that affect the mucous membrane of the mouth and throat | 100 mg to 200 mg once daily or 200 mg three times per week as long as you are at risk of an infection |
| To treat genital yeast infection | 150 mg as a single dose |
| To prevent recurrent fungal infection in the vagina | 150 mg every third day in a total of 3 doses (day 1, 4, and 7) and then once a week for 6 months as long as you are at risk of getting an infection |
| To treat fungal infections of the skin and nails | Depending on the site of infection 50 mg once a day, 150 mg once a week, 300 to 400 mg once a week for 1 to 4 weeks (up to 6 weeks in athlete’s foot, in the treatment of nail infection until the infected nail has been replaced ) |
| To prevent infection caused by Candida (if you have a weakened immune system) | 200 mg to 400 mg once daily as long as you are at risk of an infection |
Use in adolescents between 12 and 17 years of age
Use the dose as prescribed by the doctor (as recommended for either adults or children).
Use in children up to 11 years
The maximum dose for children is 400 mg daily.
Dose one is based on the child’s weight in kg.
| Infection | Daily dose |
| Fungal infections of the mouth and throat caused by Candida – dose, and duration of treatment depends on how severe the infection is and where it is located | 3 mg per kg of body weight (6 mg per kg of body weight once daily can be given on the first day) |
| Meningitis caused by cryptococci or internal fungal infections caused by Candida | 6 mg to 12 mg per kg of body weight once daily |
| To prevent recurrent meningitis caused by cryptococci | 6 mg per kg of body weight once daily |
| To prevent the child from getting an infection caused by Candida (if the child has a weakened immune system) | 3 mg to 12 mg per kg of body weight once daily |
Children between 0 and 4 weeks
Children between 3 and 4 weeks:
- The same dose as above is given every other day. The maximum dose is 12 mg per kg of body weight every other day (48 hours).
Children younger than 2 weeks:
- The same dose as above is given every third day. The maximum dose is 12 mg per kg of body weight every three days (72 hours).
The doctor may prescribe other doses to you than those listed here. Always use Solona as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Older
The usual dose of one for adults can be used unless you have kidney problems.
Patients with kidney problems
Your doctor may change the dose depending on your kidney function.
If you have used too much Solona
You may feel sick if you take too many capsules at once. If you have ingested too much or if e.g. a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice. The symptoms of a possible overdose may be that you start to hear, see, feel and think things that are not real (hallucinations and paranoid behavior). Treatment of the symptoms and gastric lavage may be necessary in case of overdose.
If you forget to use Solona
Do not take a double dose to make up for the missed dose. If you forget a dose, take it as soon as you remember. If it is almost time for the next dose, do not take the missed dose.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, Solona can cause side effects, although not everybody gets them.
Stop using Solona and go to the emergency department immediately if you experience any of the following symptoms:
- widespread rash, fever, or swollen lymph nodes (DRESS or drug hypersensitivity reaction), have been reported (occurring in an unknown number of users)).
Some people develop allergic reactions, although serious allergic reactions are rare. If you experience side effects, talk to your doctor or pharmacist. This also applies to side effects that are not mentioned in this information
If you experience any of the following symptoms, contact your doctor immediately.
- sudden wheezing, difficulty breathing, or a tight feeling in the chest
- swelling of the eyelids, face, or lips
- itching all over the body, skin redness or itching, red spots
- rash
- severe skin reactions, e.g. a blistering rash (this may affect the mouth and tongue).
Solona can affect your liver. Signs of liver damage include:
- fatigue
- decreased appetite
- vomiting
- yellowish skin or yellowish whites of the eyes (jaundice).
If any of these occur, stop taking Solona and contact your doctor immediately.
Other side effects ar
If any side effects get worse or if you notice any side effects not mentioned in this information, contact your doctor or pharmacist.
Common side effects (which may affect up to 1 in 10 users) are:
- headache
- discomfort in the stomach, diarrhea, nausea, vomiting
- elevated liver values
- rash
Uncommon side effects (may affect up to 1 in 100 users) are:
- reduced amount of red blood cells which can lead to pale skin and cause weakness and shortness of breath
- decreased appetite
- difficulty sleeping, drowsiness
- convulsions, dizziness, spinning sensation, tingling, tingling or numbness, changes in taste
- constipation, indigestion, flatulence, dry mouth
- muscle pain
- liver damage and yellowing of the skin and eyes (jaundice)
- streaks in the skin, blistering ( hives ), itching, sweating
- fatigue, general malaise, fever
Rare side effects (may affect up to 1 in 1,000 users) are:
- reduced number of white blood cells that help defend the body against infection and reduced number of blood cells that help stop bleeding
- red or purple discoloration of the skin which may be caused by a reduced number of blood platelets or other changes in the blood
- elevated blood cholesterol and blood fat values
- reduced level of potassium in the blood
- tremors
- abnormal EKG, changes in pulse or heart rhythm
- liver failure
- allergic reactions (sometimes severe), including widespread rash with blistering and peeling skin, severe skin reactions, and swelling of the lips or face
- hair loss
How to store Solona
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the packaging after EXP. The expiration date is the last day of the specified month.
Store at a maximum of 25°C.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to deal with medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is fluconazole. Each hard capsule contains 150 mg fluconazole .
- Other ingredients are Capsule contentsLactose monohydrate, pregelatinized corn starch, colloidal anhydrous silica, and magnesium stearate.
Capsule shell
Solona 150 mg: Gelatin, titanium dioxide (E171)
Appearance and package sizes of the medicine
Hard capsules
Appearance
Solona150 mg: white top with white capsule, hard gelatin capsules filled with white powder
Package sizes
1, 2, 4, 6, 7, 10, 12, 14, 20, 21, 28, 30, 50, 60, 90, 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Actavis Group PTC EHF.
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