20 mg, 30 mg, 80 mg soft capsule
Vinorelbee
What Vinorelbine Orifarm is and what it is used for
Vinorelbine Orifarm contains the active substance vinorelbine (as tartrate). It belongs to a group of drugs called vinca alkaloids and is used to treat cancer.
Vinorelbine Orifarm is used to treat certain types of lung cancer and certain types of breast cancer in patients over 18 years of age.
Vinorelbine contained in Vinorelbine Orifarm may also be approved to treat other diseases not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Vinorelbine Orifarm
Do not use Vinorelbine Orifarm
- if you are allergic to vinorelbine, to any other cancer medicine in the vinca alkaloid group, or to any of the other ingredients of this medicine (listed in section 6)
- if you have an intestinal disease that affects how you assimilate food
- if you have previously had part of your stomach or small intestine removed
- if you have a low number of white blood cells or platelets or if you have or have recently had a severe infection (in the last two weeks)
- if you are breastfeeding
- if you need long-term oxygen treatment
- if you plan to be vaccinated or have recently been vaccinated against yellow fever
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Vinorelbine Orifarm:
- if you have previously had a heart attack or severe chest pain
- If your ability to cope with everyday activities is severely impaired.
- If you have had radiotherapy with a radiation area that included the liver.
- If you have symptoms of infection (such as fever, chills, joint pain, or cough).
- if you plan to get vaccinated. Live attenuated vaccines (eg against measles, mumps, or rubella) should not be used together with Vinorelbine Orifarm, as they may increase the risk of life-threatening vaccine disease.
- If you have severe liver disease unrelated to your cancer.
- If you are pregnant.
Before and during treatment with Vinorelbine Orifarm, your blood will be tested to check that it is safe for you to receive treatment. If the results of these tests are not satisfactory, the treatment will be postponed and further tests will be performed until the values return to normal.
Children and young people
This medicine must not be given to children under 18 years of age.
Other medicines and Vinorelbine Orifarm
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The doctor must be particularly attentive if you are taking the following medicines:
- medicines that thin the blood (blood thinners); the dose may need to be changed
- antiepileptic drugs (eg, carbamazepine and phenytoin ) because of the risk of seizures; it may also reduce the effect of vinorelbine
- other anticancer medicines (eg mitomycin C) due to the risk of breathing difficulties and rarely pneumonitis and (eg lapatinib and cisplatin) due to the risk of blood cell disease
- medicines that suppress the immune system (e.g. ciclosporin and tacrolimus) due to the risk of very severe immunosuppression
- you should not receive yellow fever vaccine and live attenuated vaccines because of the risk of fatal generalized vaccine disease (see section 2 “Do not take Vinorelbine Orifarm”
- medicines to treat fungal infections (eg ketoconazole, itraconazole, voriconazole, and posaconazole) as they may increase the risk of vinorelbine side effects
- antibiotics (eg rifampicin) as they may reduce the effect of vinorelbine
- antibiotics (eg clarithromycin and telithromycin) as they may increase the effect of vinorelbine
- sedative medicines ( barbiturates ) as they can reduce the effect of vinorelbine
- (Traditional) herbal medicines (St. John’s wort) as they may reduce the effect of vinorelbine
- HIV medicines because they can increase the effect of vinorelbine
A combination of Vinorelbine Orifarm and other medicines, which are known to be toxic to the bone marrow (affecting the white and red blood cells and platelets), may increase certain side effects.
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, as there may be risks to the baby. You should not take Vinorelbine Orifarm if you are pregnant.
Do not take Vinorelbine Orifarm if you are breastfeeding.
Women of childbearing potential must use effective contraception during treatment and up to 3 months after treatment.
Men treated with Vinorelbine Orifarm are advised not to make a woman pregnant during treatment and up to 3 months after the last capsule. Discuss with the doctor whether it is possible to save sperm in a sperm bank before starting treatment with Vinorelbine Orifarm.
Driving ability and use of machinery
No studies have been conducted on the effects on the ability to drive and use machines. However, you should not drive if you feel ill or if your doctor advises you not to drive.
You are 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. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Vinorelbine Orifarm contains Sorbitol
Each soft capsule containing 20 mg of vinorelbine contains 38 mg of sorbitol.
Each soft capsule containing 30 mg of vinorelbine contains 60 mg of sorbitol.
Each soft capsule containing 80 mg vinorelbine contains 100 mg sorbitol.
How to use Vinorelbine Orifarm
Before and during treatment with Vinorelbine Orifarm, the doctor will check your blood. The doctor will tell you how many capsules and what strength you should take, how often you should take the capsules, and for how long. This is determined by your weight, height, your blood test results, and how you feel.
The total dose must never exceed 160 mg per week.
You must never take Vinorelbine Orifarm more than once a week.
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
Before opening the blister card with Vinorelbine Orifarm, check that the capsule is intact. The liquid contents of the capsules are harmful in contact with skin, mucous membranes, or eyes. If this happens, you must immediately wash the area thoroughly.
Do not swallow a damaged capsule, return it to a doctor, hospital, or pharmacy.
Instructions for opening the blister card:
- Cut the blister card along the black dashed line.
- Peel off the soft plastic film
- Push the capsule out through the aluminum foil
Intake of Vinorelbine Orifarm:
- Swallow the Vinorelbine Orifarm capsule whole with water, preferably with a light meal to reduce the risk of nausea.
- Do not chew, suck or dissolve the capsules.
- If you accidentally chew or suck on the capsule, rinse your mouth thoroughly with water and consult a doctor immediately.
- If you vomit a few hours after taking a Vinorelbine Orifarm capsule, contact your doctor and do not take another dose.
If you are taking anti-nausea medicine
Vomiting may occur with Vinorelbine Orifarm (see section 4 “Possible side effects”). If your doctor has prescribed an anti-nausea medication, always take it as directed by the doctor. Take Vinorelbine Orifarm with a light meal to reduce the risk of nausea.
If you have used too much Vinorelbine Orifarm
If you have ingested too much Vinorelbine Orifarm or if e.g. If a child has ingested the medicine by mistake, immediately contact a doctor or hospital for an assessment of the risk and advice.
Serious symptoms related to your blood levels may occur and you may develop signs of infection (such as fever, chills, and cough). You may also become severely constipated.
If you forget to use Vinorelbine Orifarm
Do not take a double dose to make up for a missed dose. Contact the doctor who can decide if you should take a dose at a different time.
If you stop using Vinorelbine Orifarm
Your doctor will decide when to stop treatment. If you want to stop treatment earlier, discuss other options with your doctor.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects:
If you develop any of the following symptoms, contact your doctor immediately:
- Signs of severe infection such as cough and fever (Common: may affect up to 1 in 10 people).
- Severe dizziness and feeling faint when you stand up This may be a sign of a severe drop in blood pressure (Common: may affect up to 1 in 10 people).
- Severe constipation with abdominal pain when you have not had a bowel movement for several days (Uncommon: may affect up to 1 in 100 users).
- Very low blood pressure, fainting with weak pulse, paleness, blue lips, and nails (Rare: may affect up to 1 in 1,000 users).
- Severe chest pain that you don’t recognize. This may be due to disturbances in the functioning of the heart due to insufficient blood flow, so-called ischemic heart disease, or heart attack (Rare: may affect up to 1 in 1,000 users).
- Shortness of breath, dizziness, low blood pressure, rash all over the body, or swelling of the eyelids, face, lips, or throat, which may be signs of an allergic reaction (Reported: occurs in an unknown number of users).
- High fever, chills, general weakness, possibly cold arms and legs due to blood poisoning (complicated sepsis ) (Has been reported: occurring in an unknown number of users).
Other side effects:
Very common: may affect more than 1 in 10 users
- Stomach discomfort, nausea, vomiting, diarrhea, constipation, abdominal pain.
- Decreased number of red blood cells (anemia) which can make your skin pale and cause weakness or shortness of breath.
- Decrease in the number of white blood cells which can increase the risk of infection.
- Reduced number of blood platelets, which increases the risk of bleeding or bruising.
- Loss of some reflexes, sometimes with an altered sense of touch.
- Inflammation or sores in the mouth or throat.
- Hair loss, usually in a mild form.
- Fatigue.
- Unpleasant feeling.
- Fever.
- Weight loss, loss of appetite.
- Infection caused by bacteria, viruses, or fungi.
Common: may affect up to 1 in 10 users
- Neuromotor disorders (difficulty coordinating muscle movements).
- Vision changes.
- Respiratory distress.
- Difficulty urinating.
- Difficulty sleeping.
- Cough.
- Headache.
- Dizziness.
- Changed taste experience.
- Inflammation of the pharynx or esophagus, difficulty swallowing food and liquids.
- High blood pressure.
- Liver disease.
- Skin reactions.
- Weight gain.
- Joint pain, pain in the jaw, muscle pain, pain in different parts of the body and at the tumor site.
- Problems in the genitals and urinary tract.
- Frostbite.
Uncommon: may affect up to 1 in 100 users
- Heart failure can cause shortness of breath and ankle swelling, heart rhythm disturbances.
- Difficulty coordinating muscle movements.
Has been reported: occurring in an unknown number of users
- Low levels of sodium in the blood can cause symptoms such as tiredness, confusion, muscle twitching, and unconsciousness.
- Bleeding in the gastrointestinal tract.
- Heart attack
- A general infection combined with a reduced number of white blood cells ( neutropenic septicemia).
Vinorelbine is also marketed as a concentrate for infusion solution, a solution that is given intravenously into a blood vessel. The list below only contains side effects that have been reported with vinorelbine concentrate for infusion and have not been observed in connection with your treatment, but occurrence cannot be excluded.
Uncommon: may affect up to 1 in 100 users
- Infection in the blood (blood poisoning).
- Difficulty breathing ( bronchospasm ).
- Cold hands and feet.
- A sudden feeling of heat and skin redness on the face and neck.
Rare: may affect up to 1 in 1,000 users
- Lung disease (interstitial pneumopathy) especially with concomitant treatment with mitomycin C which is another anticancer drug.
- Severe pain in the abdomen and back ( inflammation of the pancreas).
Has been reported: occurring in an unknown number of users
- The low sodium levels in the blood and concentrated urine (SIADH).
As changes in the blood can occur, doctors can prescribe blood tests to check this (low number of white blood cells, anemia and/or low number of platelets, effect on liver or kidney function, and salt balance in the body).
How to store Vinorelbine Orifarm
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 in a refrigerator (2 o C – 8 o C).
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
For safety reasons, any remaining capsules should be returned to the hospital or pharmacy for disposal according to local regulations for cytostatics.
Contents of the packaging and other information
Contents declaration
- The active substance is vinorelbine (as tartrate) 20, 30, and 80 mg
- Other ingredients are Solution in the capsule: Makrogol 400; polysorbate 80; water, purified. Capsule shell 20 mg: Gelatin; sorbitol, liquid, partially dehydrated; titanium dioxide (E171); yellow iron oxide (E172); water, purified; triglycerides, medium chain.Capsule shell 30 mg: Gelatin; sorbitol, liquid, partially dehydrated; titanium dioxide (E171); red iron oxide (E172); water, purified; triglycerides, medium chain.Capsule shell 80 mg: Gelatin; sorbitol, liquid, partially dehydrated; titanium dioxide (E171); yellow iron oxide (E172); water, purified; triglycerides, medium chain.
Appearance and package sizes of the medicine
Vinorelbine Orifarm 20 mg: oval light brown soft capsule.
Vinorelbine Orifarm 30 mg: oblong pink soft capsule.
Vinorelbine Orifarm 80 mg: oblong light yellow soft capsule.
Vinorelbine Orifarm 20 mg, 30 mg and 80 mg
PVC/PVDC-Alu blister with child-resistant paper layer: 1 soft capsule.
Orifarm Generics A/S
Energivej 15
5260 Odense S
Denmark
Local representative:
Orifarm Generics AB,
Box 56048
102 17 Stockholm
info@orifarm.com
This medicine is approved in the European Economic Area under the names:
Denmark, Sweden, Norway, and Finland: Vinorelbine Orifarm