Strefen – Flurbiprofen uses, dose and side effects

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8.75 mg lozenges
flurbiprofen 8.75 mg

What Strefen lozenges are and what they are used for

Strefen lozenges contain flurbiprofenflurbiprofen belongs to a group of pain-relieving drugs called non-steroidal anti-inflammatory drugs ( NSAIDs ), which have analgesic, antipyretic and anti-inflammatory properties. These drugs work by changing the body’s response to pain, swelling, and fever.

Strefen lozenges are used for short-term symptom relief in sore throats, such as sore, painful, and swollen throats and difficulty swallowing in adults and children over 12 years of age.

The flurbiprofen found in Strefen may also be approved to treat other conditions not mentioned in this product information. Ask a doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before taking Strefen lozenges

Do not take these lozenges if you:

• are allergic (hypersensitive) to flurbiprofen or any of the other ingredients in Strefen (listed in section 6).

• ever had asthma, unexpected wheezing, shortness of breath, runny nose, facial swelling, or an itchy rash ( hives ) after taking acetylsalicylic acid or any other NSAID preparation.

• have or have ever had two or more episodes of stomach ulcers, ulcers in the intestines, or bleeding in the gastrointestinal tract

• have had bleeding or holes in the stomach or intestines, severe colitis (inflammation of the colon), or blood disorders when you have previously taken an NSAID preparation.

• taking high doses of acetylsalicylic acid or other NSAID preparations (such as celecoxibibuprofen, diclofenac sodium, etc.).

• during the last three months of pregnancy.

• have or have ever had severe heart, kidney, or liver disease.

• is under 12 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before taking Strefen lozenges if you:

• have ever had asthma or suffered from allergies

• have tonsillitis (strep throat) or think you may have a bacterial throat infection (as you may need antibiotics )

• have heart, kidney, or liver problems

• have had a stroke

• have had any history of bowel disease ( ulcerative colitisCrohn’s disease )

• have a chronic ( autoimmune ) disease where the body’s immune system attacks its own body, such as systemic lupus erythematosus and mixed connective tissue disease.

• are older, as the likelihood of you developing the side effects listed in this leaflet increases

• are you in the first 6 months of pregnancy or are breastfeeding

• cannot tolerate certain sugars

While using Strefen lozenges

• At the first sign of a skin reaction (rash, scaly skin, blisters) or other signs of an allergic reaction, stop taking the lozenge and contact a doctor immediately.

• Report any unusual symptoms (especially bleeding) to a doctor.

• If you do not improve, get worse or if new symptoms appear, contact a doctor.

• Medicines such as Strefen lozenges may be associated with a slightly increased risk of suffering a heart attack ( myocardial infarction ) or stroke. All risks increase with higher doses and long-term treatment. Do not exceed the recommended dose or duration of treatment (3 days).

Children

Children should not use the medicine under 12 years of age.

Special warnings

If you have heart problems, have had a stroke, or think you may be at risk of these conditions (eg if you have high blood pressure, diabetes, high cholesterol, or smoke) you should discuss the treatment with your doctor or pharmacist.

Other medicines and Strefen lozenges

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, even those without a prescription. In particular, tell them if you are taking:

• low-dose aspirin (up to 75 mg a day)

• medicines for high blood pressure or heart failure (antihypertensive medicines, cardiac glycosides)

• diuretics ( diuretics, including potassium-sparing drugs)

• medicines that thin the blood ( anticoagulants, platelet inhibitors)

• medicines for gout (probenecid, sulfinpyrazone)

• other NSAID preparations or steroids (such as celecoxibibuprofen, diclofenac sodium, or prednisolone )

mifepristone (a medicine used to terminate a pregnancy)

• quinolone antibiotics (such as ciprofloxacin )

ciclosporin or tacrolimus (to suppress the immune system).

• phenytoin (to treat epilepsy )

methotrexate (to treat autoimmune diseases or cancer)

• lithium or SSRI preparations (for depression)

• oral diabetes medicines (to treat diabetes )

zidovudine (to treat HIV ).

Strefen lozenges with food and drink

Alcohol should be avoided during treatment with Strefen lozenges because it increases the risk of bleeding in the gastrointestinal tract.

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.

Pregnant women should not use Strefen during the last three months of pregnancy.

If you are in the first 6 months of pregnancy or breastfeeding, talk to your doctor before taking these lozenges.

Ingestion of Strefen should be avoided by women planning a pregnancy or who are pregnant.

Strefen lozenges belong to a group of drugs ( NSAIDs ) that can make it harder to get pregnant.

This effect ceases when the treatment is stopped.

Driving ability and use of machinery

No studies on the effects on the ability to drive or use machines have been performed. Dizziness and visual disturbances are, however, possible side effects after taking NSAIDs. If you experience these symptoms, do not drive or use machines.

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. 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.

Strefen lozenges contain glucose and sucrose

Strefen lozenges contain 1.069 g of glucose and 1.407 g of sucrose per lozenge. This should be taken into account in patients with diabetes mellitus.

If you have an intolerance to certain sugars, you should consult your doctor before taking these lozenges.

This medicine contains only very low levels of gluten (from wheat starch) and is considered “gluten-free”. It is very unlikely that it will cause problems if you have gluten intoleranceceliac disease ) 1 lozenge contains no more than 21.38 micrograms of gluten.

If you are allergic to wheat (a disease other than gluten intolerance) you should not use this medicine.

This medicine contains fragrances with citral, citronellol, d-limonene, farnesol, geraniol, and linalool.

Citral, citronellol, d-limonene, farnesol, geraniol, and linalool can cause allergic reactions.

Sulfur dioxide (E220) can in rare cases cause serious hypersensitivity reactions and spasms in the trachea.

Butylhydroxyanisole (E320) can cause local skin reactions (e.g. contact dermatitis) or be irritating to the eyes and mucous membranes

How to take Strefen lozenges

Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.

The recommended dose is for Adults and children from the age of 12:

• Take a lozenge in your mouth and let it dissolve slowly.

• Keep moving the lozenge around in your mouth while it dissolves.

• The lozenges should start working within 30 minutes.

• Then take a lozenge every 3-6 hours, if needed.

• Do not take more than 5 lozenges per day.

Do not give Strefen lozenges to children under 12 years of age.

These lozenges are intended for short-term use only.

You should take as few lozenges as you need for the shortest time necessary to relieve the symptoms.

If irritation occurs in the mouth, treatment with flurbiprofen should be discontinued.

Do not take Strefen lozenges for more than 3 days unless your doctor has recommended it. If you do not improve or if you get worse, or if new symptoms appear, talk to a doctor or pharmacist.

If you have taken too many Strefen lozenges

If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.

The symptoms of overdose can be nausea or vomiting, stomach pain, or, more rarely, diarrhea. Ringing in the ears, headache, and bleeding in the gastrointestinal tract are also possible symptoms.

If you have any further questions about this medicine, ask your doctor or pharmacist.

If you forget to take Strefen lozenges

Do not take a double dose to make up for a missed tablet.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

STOP TAKING this medicine and call your doctor immediately if you develop:

• signs of allergic reactions such as asthma, unexpected wheezing, shortness of breath, itching, runny nose, or skin rash.

• swelling of the face, tongue, or throat leading to breathing difficulties, palpitations, and a drop in blood pressure leading to shock (These may occur when the medicine is first used).

• serious skin reactions such as scaly skin, blisters, or peeling skin.

Talk to your doctor or pharmacist if you notice any of the following other side effects or any side effects not mentioned:

Common (affects 1 in 10 users) :

headache, Dizziness

• throat irritation

• mouth ulcers or pain in the mouth

sore throat

• discomfort or abnormal sensation in the mouth (warming sensation, burning sensation, tingling sensation, etc.)

• nausea, diarrhea

• tingling and itching sensation in the skin

Uncommon (affects 1 in 100 users)

• drowsiness

blisters in the mouth or throat, numbness in the throat

• swollen abdomen, abdominal pain, gas, constipation, indigestion, vomiting

• dry mouth

• burning sensation in the mouth, changes in taste

• skin rash, itchy skin

fever, pain

• sleepiness or difficulty sleeping

• worsened asthma, wheezing, shortness of breath

• reduced feeling in the throat

Rare (occurs in 1 in 1,000 users)

• acute allergic reaction

Frequency not known ( cannot be calculated from available data)

• anemia, thrombocytopenia (low number of blood platelets which can cause bruising and bleeding)

• swelling ( edema ), high blood pressure, heart failure, heart attack.

• serious skin reactions, for example, bullous reactions, including Stevens-Johnson syndrome, Lyell’s syndrome, and toxic epidermal necrolysis.

• hepatitis (inflammation of the liver).

How Strefen lozenges should be stored

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 the original packaging.

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.

Contents of the packaging and other information

Contents declaration

  • The active substance (which makes the medicine effective) is flurbiprofen 8.75 mg.
  • Other ingredients are macrogol 300, potassium hydroxide (E525), lemon flavor (contains butyl hydroxyanisole (E320)), levomenthol, invert sugar (honey), and liquid glucose (contains wheat starch and sulfur dioxide (E220)), and liquid sucrose.

Appearance and package sizes of the medicine

The lozenges are round and embossed with the brand’s logo on both sides and are opaque from pale yellow to brown.

The packages contain

8 lozenges (over-the-counter)

16 lozenges (over-the-counter)

24 lozenges (prescription)

36 lozenges (prescription)

Not all pack sizes may be marketed

Marketing authorization holder and manufacturer

Marketing Authorisation Holder

Reckitt Benckiser Healthcare (Scandinavia) A/S

Vandtårnsvej 83A

DK-2860 Søborg Denmark

Phone: 08-20 00 70

Manufacturer

RB NL Brands BV

WTC Schiphol Airport,

Schiphol Boulevard 207,

1118 BH Schiphol,

Netherlands

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