SAFTEY

Potafast

Originator and patented brand

Safety

Medication safety is one of the most important concerns in healthcare, as it directly impacts patient well-being and health outcomes. Ensuring the safety of medications begins with numerous pre-market tests in clinical trials, where drugs are assessed for their effectiveness and safety profile. Dosing accuracy and proper administration are fundamental in preventing adverse events and optimizing the benefits of medication. Drug interactions, which can lead to harmful side effects, require careful consideration when multiple medications are prescribed to a patient. A thorough risk-benefit assessment guides clinical decision-making, helping healthcare professionals weigh the potential benefits against the known or potential risks of a medication. Overall, medication safety is a collaborative effort involving various people, working together to provide effective and safe treatments for a wide range of medical conditions while minimizing potential risks and adverse effects.

When should you not use Potafast:

  • If you are allergic to one of the ingredients or any other NSAID medications.
  • After taking acetylsalicylic acid or other analgesic or antirheumatic medications (so-called nonsteroidal anti-inflammatory drugs or NSAIDs)
  • If you experience breathing difficulties
  • If you experience allergic skin reactions, for example, swelling of the face, lips, tongue, throat, and/or limbs (signs of angioedema).
  • In the third trimester of pregnancy
  • Before or after heart bypass surgery
  • If you have active gastric ulcers and/or active duodenal ulcers (ulcers at the first part of the small intestine), gastrointestinal bleeding, or perforation.
  • If you experience symptoms such as blood in stool or black stool
  • If you have a chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis), liver or kidney failure, or severe heart failure, for treatment of pain occurring after coronary artery bypass graft surgery (or after being on a heart-lung machine)
  • In children under the age of 14.

 

If any of these circumstances apply to you, tell your doctor and do not take Potafast. Your doctor will decide whether this medication is suitable for you

Tell your doctor if you believe that you may be allergic.

When should caution be taken when using Potafast?

  • Cardiovascular disease (such as uncontrolled high blood pressure, heart failure, established coronary heart disease, or peripheral arterial disease.
  • If you have recently undergone gastrointestinal surgery or intend to undergo gastrointestinal surgery in the near future, cardiovascular disease or significant risk factors such as high blood pressure, abnormal blood lipid levels (cholesterol, triglycerides), diabetes, or if you smoke.
  • Particular caution is also recommended if you are taking Potafast at the same time as other anti-inflammatory medications (such as acetylsalicylic acid or corticosteroids), anticoagulants or selective serotonin reuptake inhibitors (SSRI) (drugs to treat depression)
  • If you have asthma
  • If you have liver diseases
  • If you have kidney diseases
  • If you have blood clotting disorders or other problems concerning the blood including a rare liver condition known as porphyria.
  • If you have myocardial infarction, stroke, or venous thrombosis in your medical history, or if you have risk factors (such as hypertension, diabetes, high blood lipid levels, smoking).

What should I be aware of when using Potafast:

  • This medication may reduce your ability to react, drive, and use equipment or machines.
  • Potafast should not be used for the sole purpose of reducing fever.
  • Potafast may lessen signs of an infection (e.g. headache, increase in body temperature) and can therefore make them more difficult to detect and harder to treat appropriately.
  • This medication contains 50 mg of aspartame per sachet. Aspartame is a source of phenylalanine and may be harmful to patients with phenylketonuria (PKU), a rare inherited disorder that causes phenylalanine to accumulate as the body is not able to metabolize it sufficiently.
  • This medication contains less than 1 mol sodium (23 mg) per sachet which makes it essentially free from sodium.

Before taking Potafast, tell your doctor or pharmacist about all your medical conditions, including if you:

  • Have heart diseases
  • Have kidney disease or kidney failure
  • Have liver diseases
  • Have allergies
  • Have asthma
  • Have hay fever
  • Have blood clotting disorders
  • Have Porphyria

If you are taking:

  • Other anti-inflammatory medications (such as acetylsalicylic acid or corticosteroids)
  • Anticoagulants
  • Selective serotonin reuptake inhibitors (SSRI) (medications to treat depression)
  • Lithium
  • Digoxin (for heart problems)
  • Diuretics (to increase urine excretion)
  • ACE inhibitors or beta-blockers (for hypertension and heart problems)
  • Medications to treat diabetes (e.g. metformin) except insulin
  • Methotrexate (for arthritis and cancer)
  • Ciclosporin or tacrolimus (for organ transplants)
  • Trimethoprim (for urinary tract infections)
  • Quinolone antibiotics (to fight infections)
  • Voriconazole (to treat fungal infections)
  • Phenytoin (to treat epilepsy)
  • Rifampicin (to treat bacterial infections).

When to contact your doctor?

If you notice signs or symptoms of cardiovascular strain such as chest pain, shortness of breath, fatigue, dysarthria, or other severe side effects when using Potafast, contact your doctor immediately.

What side effects can Potafast have?

The following side effects may occur when using Potafast Common (affecting 1 to 10 users in every 100)

  • Headaches
  • Dizziness
  • Vertigo
  • Nausea
  • Vomiting
  • Diarrhea
  • Gastrointestinal disorders
  • Abdominal pain
  • Flatulence
  • Decreased appetite
  • Rash
  • Fluid retention
  • Swelling
  • Increased blood pressure
  • Changes in liver function (e.g. increased concentration of liver enzymes in the blood)

Uncommon (affecting 1 to 10 users in every 1,000)

  • Sudden and oppressive chest pain (signs of a myocardial infarction)
  • Shortness of breath
  • Breathing difficulties when lying down
  • Swelling of the feet and legs (signs of heart failure)

Rare (affecting 1 to 10 users in every 10,000)

  • Hypersensitivity reactions with swelling of the face, mouth, and limbs (until a decrease in pressure and shock)
  • Asthma
  • Drowsiness
  • Gastrointestinal inflammation and ulcers
  • Vomiting blood
  • Bloody diarrhea
  • Impaired liver function
  • Inflammation of the liver
  • Jaundice (very rarely liver failure)
  • Hives are rare while the frequencies of sudden onset of chest pain and allergic reactions (signs of Kounis Syndrome) are unknown.

Very rare (affecting less than 1 user in every 10,000)

  • Changes in blood count
  • Unusual bleeding
  • Bruising
  • Mental health problems (including insomnia and irritability)
  • Disturbances in perception
  • Memory problems
  • Cramps
  • Anxiety
  • Tremors
  • Disturbance in taste perception
  • Altered vision
  • Poor vision
  • Noises in the ears (tinnitus)
  • Decreased hearing ability
  • Stiff neck
  • Inflammation of blood vessels, lungs, and large intestine
  • Constipation
  • Inflammation of the pancreas, mucous membrane of the mouth, and the tongue
  • Eczema, itching, skin redness and inflammation, hair loss and bleeding skin
  • Acute kidney problems and blood in the urine are very rare.

If you experience any of these side effects, you should inform your doctor.

You should consult your doctor if you notice any side effects, especially if the side effects are not described in this patient information leaflet.

What else needs to be considered?

  • The medication should not be used after the date marked "EXP" on the pack.
  • Storage instructions
  • Keep this product out of reach of children.
  • Protect sachets from moisture and do not store at temperatures above 25 °C