Phrenilin Forte

Generic name: Butalbital And Acetaminophen
Drug class: Analgesic combinations

Usage of Phrenilin Forte

Butalbital and acetaminophen combination is used to relieve symptoms of tension (or muscle contraction) headaches.

Butalbital belongs to the group of medicines called barbiturates. They act in the central nervous system (CNS) to produce their effects.

Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including serious liver damage. Although rare, use of acetaminophen has been reported to lead to liver transplantation and death, usually at high doses and when multiple acetaminophen-containing products have been used.

This medicine is available only with your doctor's prescription.

Phrenilin Forte side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Dizziness

lightheadedness

sleepiness

trouble breathing

Less common

Anxiety

black, tarry stools

bleeding gums

blistering, peeling, or loosening of the skin

blood in the urine or stools

chest tightness

chills

cough or hoarseness

diarrhea

difficulty swallowing

discouragement

dry mouth

excitement

fainting

false or unusual sense of well-being

fast, pounding, or irregular heartbeat or pulse

feeling sad or empty

headache

heavy eyelids

high energy

hives, itching, skin rash

hot spells

hyperventilation

irregular heartbeats

irritability

joint or muscle pain

lack of appetite

loss of interest or pleasure

lower back or side pain

mental confusion

nervousness

painful or difficult urination

pinpoint red spots on the skin

puffiness or swelling of the eyelids or around the eyes, face, lips or tongue

red irritated eyes

red skin lesions, often with a purple center

restlessness

seizures

shaky feeling

sluggishness

sore throat

sores, ulcers, or white spots in the mouth or on the lips

trouble concentrating

trouble sleeping

unusual bleeding or bruising

unusual tiredness or weakness

Incidence not known

Dark urine

loss of appetite

nausea or vomiting

stomach pain, severe

yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Black, tarry stools

bloody or cloudy urine

blurred vision

change in consciousness

chills

confusion

dark urine

difficult or painful urination

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fever

headache

irregular, fast or slow, or shallow breathing

itching

light-colored stools

loss of appetite

loss of consciousness

nausea

pale or blue lips, fingernails, or skin

sleepiness

stomach pain

sudden decrease in amount of urine

sweating

trouble breathing

unpleasant breath odor

unusual tiredness or weakness

vomiting of blood

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Bloated

constipation

continuing ringing or buzzing or other unexplained noise in the ears

dry mouth

earache

excess air or gas in the stomach or intestines

full feeling

hearing loss

heartburn

increased sweating

indigestion

leg pain

passing gas

stuffy nose

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking Phrenilin Forte

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of butalbital and acetaminophen combination in children younger than 12 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of butalbital and acetaminophen combination in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alfentanil

Alprazolam

Amobarbital

Anisindione

Aprobarbital

Barbital

Butabarbital

Calcium Oxybate

Carisoprodol

Chloral Hydrate

Chlordiazepoxide

Chlorzoxazone

Clarithromycin

Clonazepam

Clorazepate

Dantrolene

Darunavir

Diazepam

Dicumarol

Doxorubicin

Doxorubicin Hydrochloride Liposome

Drospirenone

Esketamine

Estazolam

Eterobarb

Ethchlorvynol

Ethinyl Estradiol

Etonogestrel

Flunitrazepam

Flurazepam

Halazepam

Heptabarbital

Hexobarbital

Imatinib

Isocarboxazid

Isoniazid

Ketazolam

Linezolid

Lorazepam

Lormetazepam

Magnesium Oxybate

Medazepam

Mephenesin

Mephobarbital

Meprobamate

Metaxalone

Methocarbamol

Methohexital

Methylene Blue

Midazolam

Nifedipine

Nitrazepam

Norethindrone

Norgestimate

Norgestrel

Oxazepam

Ozanimod

Pentobarbital

Phenelzine

Phenindione

Phenobarbital

Phenprocoumon

Piperaquine

Pixantrone

Pneumococcal 13-Valent Vaccine, Diphtheria Conjugate

Potassium Oxybate

Prazepam

Primidone

Procarbazine

Quazepam

Rasagiline

Safinamide

Secobarbital

Selegiline

Sodium Oxybate

Temazepam

Thiopental

Tranylcypromine

Trazodone

Triazolam

Ulipristal

Zotepine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acenocoumarol

Carbamazepine

Fosphenytoin

Lixisenatide

Ospemifene

Phenytoin

Prednisone

St John's Wort

Warfarin

Zidovudine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Tobacco

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Cabbage

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How to use Phrenilin Forte

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much of this medicine is taken for a long time, it may become habit-forming and cause mental or physical dependence. Also, large amounts of acetaminophen may cause liver damage if taken for a long time.

Carefully check the labels of all other medicines you are using, because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours), as this may increase the risk for serious liver problems.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For tension headaches::

For oral dosage form (capsules):

Adults and children 12 years of age and older—1 or 2 capsules every 4 hours. However, the dose is usually not more than 6 capsules per day. Do not exceed 4 grams (4000 milligrams) of acetaminophen (Tylenol®) per day.

Children younger than 12 years of age—Use and dose must be determined by your doctor.

For oral dosage form (tablets):

Adults and children 12 years of age and older—1 or 2 tablets every 4 hours as needed. However, the dose is usually not more than 6 tablets per day. Do not exceed 4 grams (4000 milligrams) of acetaminophen (Tylenol®) per day.

Children younger than 12 years of age—Use and dose must be determined by your doctor.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Warnings

It is very important that your doctor check your progress while you are using this medicine, especially within the first 24 to 72 hours of treatment. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

This medicine may cause serious skin reactions (eg, acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis). Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have chest tightness, cough, dizziness, fast heartbeat, hives, rash, itching, puffiness or swelling of the eyelids, or around the eyes, face, lips, or tongue, trouble breathing or swallowing, or unusual tiredness or weakness while you are using this medicine.

This medicine may make you dizzy, drowsy, confused, or disoriented. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Do not suddenly stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping completely. This may help prevent a possible worsening of your condition and reduce the possibility of withdrawal symptoms such as confusion as to time, place, or person, hallucinations, holding false beliefs that cannot be changed by fact, seizures, or unusual excitement, nervousness, or restlessness.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Also, there may be a greater risk of liver damage if you drink 3 or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your doctor before taking any of these medicines while you are using this medicine.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Signs of an overdose include: black, tarry stools, bloody or cloudy urine, blurred vision, change in consciousness, chills, confusion, dark urine, difficult or painful urination, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, fever, headache, irregular, fast or slow, or shallow breathing, itching, light-colored stools, loss of appetite, loss of consciousness, nausea, pale or blue lips, fingernails, or skin, sleepiness, stomach pain, sudden decrease in amount of urine, sweating, trouble breathing, unpleasant breath odor, unusual tiredness or weakness, vomiting of blood, or yellow eyes or skin.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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